Does the Product Emit Radiation?

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="Information about radiation-emitting products, including determination and classification." /> <meta name="dcterms.title" content="Does the Product Emit Radiation?" /> <meta name="dcterms.creator" content="Center for Devices and Radiological Health" /> <meta name="dcterms.subject" content="FDA Activities" /> <meta name="dcterms.description" content="Information about radiation-emitting products, including determination and classification." /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.type" content="Article" /> <meta name="dcterms.source" content="FDA" /> <meta name="dcterms.audience" content="Industry" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/medical-devices/classify-your-medical-device/does-product-emit-radiation" /> <meta property="og:title" content="Does the Product Emit Radiation?" /> <meta property="og:description" content="Information about radiation-emitting products, including determination and classification." /> <meta property="og:updated_time" content="Tue, 02/21/2023 - 09:37" /> <meta property="article:publisher" content="FDA" /> <meta property="article:published_time" content="Fri, 08/09/2024 - 21:42" /> <meta property="article:modified_time" content="Tue, 02/21/2023 - 09:37" /> <meta name="google-site-verification" content="tWxlDhm4ANdksJZPj7TBmHgNoMqZCnecPp0Aa2vC9XA" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@US_FDA" /> <meta property="twitter:description" content="Information about radiation-emitting products, including determination and classification." /> <meta name="twitter:title" content="Does the Product Emit Radiation?" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@graph": [ { "@type": "Article", "headline": "Does the Product Emit Radiation?", "name": "Does the Product Emit Radiation?", "description": "Information about radiation-emitting products, including determination and classification.", "datePublished": "Fri, 08/09/2024 - 21:42", "dateModified": "Tue, 02/21/2023 - 09:37", "author": { "@type": "Organization", "name": "Center for Devices and Radiological Health" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/medical-devices/classify-your-medical-device/does-product-emit-radiation" /> <link rel="canonical" href="https://www.fda.gov/medical-devices/classify-your-medical-device/does-product-emit-radiation" /> <link rel="shortlink" href="https://www.fda.gov/node/354185" /> <script src="/files/google_tag/production/google_tag.script.js?smgeuw" defer></script> <title>Does the Product Emit Radiation? | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_nIAEFYPN7y_O0y9dA__6_ZBSGy8omYOK6rvMeZ1warY.css?delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <script src="https://script.crazyegg.com/pages/scripts/0024/3700.js" async></script> <script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=FDA&sdor=fda.gov&dclink=true" language="javascript" id="_fed_an_ua_tag"></script> <script>window.dataLayer = window.dataLayer || [];function gtag(){dataLayer.push(arguments)};gtag("js", new Date());gtag("set", "developer_id.dMDhkMT", true);gtag("config", "G-273DTKB5QW", {"groups":"default","page_placeholder":"PLACEHOLDER_page_location","allow_ad_personalization_signals":false});</script> </head> <body class="role-anonymous path-node page-node-type-article has-glyphicons"> <div id="quicklinks" class="sr-only"> <ul> <li><a href="#main-content" class="sr-only sr-only-focusable" tabindex="1">Skip to main content</a></li> <li><a href="#search-form" class="sr-only sr-only-focusable" tabindex="1">Skip to FDA Search</a></li> <li><a href="#section-nav" class="sr-only sr-only-focusable" tabindex="1">Skip to in this section menu</a></li> <li><a href="#footer-heading" class="sr-only sr-only-focusable" tabindex="1">Skip to footer links</a></li> </ul> </div> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M95XGZW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="main-container container-fluid"> <div class="row"> <header class="lcds-header container-fluid" role="heading" aria-level="1"> <div class="row us-masthead"> <div class="usa-banner col-xs-12"> <img class="usa-banner__us-flag" src="/themes/custom/preview/assets/images/US_Flag.png" alt="U.S. flag" /> <span>An official website of the United States government</span> <a id="USMenuButton" class="collapsed" data-toggle="collapse" data-target="#USABannerMenu" aria-controls="USABannerMenu">Here鈥檚 how you know <span class="toggle-indicator"> </span></a> <div class="col-xs-12 collapse usa-banner__menu" id="USABannerMenu" aria-labelledby="USMenuButton"> <div id="gov-banner" class="row usa-banner-content usa-grid usa-accordion-content" aria-hidden="true"> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-dot-gov.svg" alt="Dot gov" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The .gov means it鈥檚 official.</strong><br>Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.</p> </div> </div> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-https.svg" alt="SSL" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The site is secure.</strong><br> The <strong>https://</strong> ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.</p> </div> </div> </div> </div> </div> </div> <div class="alert alert-warning margin-left-neg-2 margin-right-neg-2 margin-top-3 margin-bottom-1"> <p>On Oct. 1, 2024, the FDA began implementing a <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More">reorganization</a> impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.</p> </div> <div class="row fda-masthead"> <div class="col-xs-4 col-md-8"> <a href="/" title="FDA Homepage"> <h1 class="fda-masthead__fda-logo">U.S. Food and Drug Administration</h1> </a> </div> <div class="col-xs-8 col-md-4"> <ul class='fda-masthead__item-list'> <li><a title="" id="btn-search" class="btn btn-default btn-sm fda-masthead__btn-search"> <span class="fa fa-search" aria-hidden="true"> </span> <span class="fda-masthead__btn-label">Search</span> </a></li> <li><a id="menu-btn" class="btn btn-default btn-sm fda-masthead__btn-menu collapsed" href="#primary-nav" data-toggle="collapse" aria-expanded="true"> <span class="fa fa-bars" aria-hidden="true"> </span> <span class='fda-masthead__btn-label'>Menu</span> </a></li> </ul> </div> <form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8" > <div class="search-popover" id="search-popover"> <div class="input-group pull-right" id="search-group"> <label class="sr-only" for="search-query">Search FDA</label> <input class="form-control search-input" id="search-query" name="s" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text" /> <span class="input-group-btn" id="input-group-btn"> <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button> </span> </div> </div> </form> </div> <nav id="primary-nav" class="lcds-primary-nav row collapse"> <div class="col-md-5 col-lg-4"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Featured</h2> <ul class="lcds-primary-nav__list lcds-primary-nav__list--featured"> <li class="lcds-primary-nav__list-item"><a href="https://www.safetyreporting.hhs.gov/smarthub#/" title="Report a Problem with an FDA Regulated Product">Report a Product Problem</a></li> <li class="lcds-primary-nav__list-item"><a href="/about-fda/contact-fda">Contact FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information/search-fda-guidance-documents">FDA Guidance Documents</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety/recalls-market-withdrawals-safety-alerts">Recalls, Market Withdrawals and Safety Alerts</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events/newsroom/press-announcements">Press Announcements</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">Warning Letters</a></li> <li class="lcds-primary-nav__list-item"><a href="/advisory-committees">Advisory Committees</a></li> <li class="lcds-primary-nav__list-item"><a href="/fda-en-espanol">En Espa&#241ol</a></li> </ul> </section> </div> <div class="col-md-7 col-lg-8"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Products</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/food">Food</a></li> <li class="lcds-primary-nav__list-item"><a href="/drugs">Drugs</a></li> <li class="lcds-primary-nav__list-item"><a href="/medical-devices">Medical Devices</a></li> <li class="lcds-primary-nav__list-item"><a href="/radiation-emitting-products">Radiation-Emitting Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/vaccines-blood-biologics">Vaccines, Blood, and Biologics</a></li> <li class="lcds-primary-nav__list-item"><a href="/animal-veterinary">Animal and Veterinary</a></li> <li class="lcds-primary-nav__list-item"><a href="/cosmetics">Cosmetics</a></li> <li class="lcds-primary-nav__list-item"><a href="/tobacco-products">Tobacco Products</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Topics</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/about-fda">About FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/combination-products">Combination Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information">Regulatory Information</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety">Safety</a></li> <li class="lcds-primary-nav__list-item"><a href="/emergency-preparedness-and-response">Emergency Preparedness</a></li> <li class="lcds-primary-nav__list-item"><a href="/international-programs">International Programs</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events">News and Events</a></li> <li class="lcds-primary-nav__list-item"><a href="/training-and-continuing-education">Training and Continuing Education</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations">Inspections and Compliance</a></li> <li class="lcds-primary-nav__list-item"><a href="/science-research">Science and Research</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Information For</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/consumers">Consumers</a></li> <li class="lcds-primary-nav__list-item"><a href="/patients">Patients</a></li> <li class="lcds-primary-nav__list-item"><a href="/industry">Industry</a></li> <li class="lcds-primary-nav__list-item"><a href="/health-professionals">Health Professionals</a></li> <li class="lcds-primary-nav__list-item"><a href="/federal-state-local-tribal-and-territorial-officials">Federal, State and Local Officials</a></li> </ul> </section> </div> </nav> </header> <div class="col-xs-12"> <div data-drupal-messages-fallback class="hidden"></div> </div> <section id="block-entityviewcontent" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <a class="lcds-button--expandable collapsed hidden-md hidden-lg" data-toggle="collapse" href="#section-nav" >In this section<span class="visible-sm-inline-block">: Classify Your Medical Device </span> </a> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav hidden-md hidden-lg collapse"> <ul class="lcds-section-nav__list"> <li> <a href="/medical-devices/overview-device-regulation/classify-your-medical-device" title="Classify Your Medical Device" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link visible-xs-block visible-sm-block"> Classify Your Medical Device </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_5 js-view-dom-id-7b51b825d3c795897d24372b0464f10bfe9dde54c017be39b7afebbd6cbc336e"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/medical-devices/classify-your-medical-device/does-product-emit-radiation" class="lcds-section-nav__link">Does the Product Emit Radiation?</a></li> <li><a href="/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device" class="lcds-section-nav__link">How to Determine if Your Product is a Medical Device</a></li> <li><a href="/medical-devices/classify-your-medical-device/medical-device-accessories" class="lcds-section-nav__link">Medical Device Accessories</a></li> <li><a href="/medical-devices/classify-your-medical-device/device-classification-panels" class="lcds-section-nav__link">Device Classification Panels</a></li> <li><a href="/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions" class="lcds-section-nav__link">Class I and Class II Device Exemptions </a></li> <li><a href="/medical-devices/classify-your-medical-device/product-code-classification-database" class="lcds-section-nav__link">Product Code Classification Database</a></li> <li><a href="/medical-devices/classify-your-medical-device/reclassification" class="lcds-section-nav__link">Reclassification</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-04f381bac268648d23868f1d150322baf4e8aff53b49a6354309715c130fe73d"> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/medical-devices">Medical Devices</a> </li> <li > <a href="/medical-devices/device-advice-comprehensive-regulatory-assistance">Device Advice: Comprehensive Regulatory Assistance</a> </li> <li > <a href="/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation">Overview of Device Regulation</a> </li> <li > <a href="/medical-devices/overview-device-regulation/classify-your-medical-device">Classify Your Medical Device</a> </li> <li > <a class="current-link">Does the Product Emit Radiation?</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/medical-devices/overview-device-regulation/classify-your-medical-device" title="Classify Your Medical Device"> Classify Your Medical Device </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Does the Product Emit Radiation?</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fmedical-devices%2Fclassify-your-medical-device%2Fdoes-product-emit-radiation" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Does%20the%20Product%20Emit%20Radiation%3F&url=https://www.fda.gov%2Fmedical-devices%2Fclassify-your-medical-device%2Fdoes-product-emit-radiation" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fmedical-devices%2Fclassify-your-medical-device%2Fdoes-product-emit-radiation&title=Does%20the%20Product%20Emit%20Radiation%3F&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Does%20the%20Product%20Emit%20Radiation%3F&body=https://www.fda.gov%2Fmedical-devices%2Fclassify-your-medical-device%2Fdoes-product-emit-radiation" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <div class="callout"> <p>Electronic Submission Software available for Lasers, Cabinet X-Ray Products, Sunlamp Products, Mercury Vapor Lamps, TVs, and Microwave Ovens - <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bdff3e96-1e0b-42ff-bc5e-c895d02ecc4a" href="/industry/fda-esubmitter/esubmitter-download-and-installation" title="eSubmitter Download and Installation">Download your copy!</a></p> </div> <ul> <li><a id="top" name="top"></a><a href="#introduction">Introduction</a></li> <li><a href="#link_1">Definition of Electronic Product Radiation</a></li> <li><a href="#link_2">Examples of Electronic Products</a></li> <li><a href="#link_3">Record and Reporting Requirements by Product</a></li> </ul> <h2><a id="introduction" name="introduction"></a>Introduction</h2> <p>FDA regulates radiation emitting electronic products. The purpose is to prevent unnecessary exposure to radiation due to the use of these products. There are specific requirements that <strong>apply to all</strong> radiation emitting electronic products in order to comply with the provisions of the Federal Food, Drug and Cosmetic (FD&C) Act. If the product is also a <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="581080c0-3afb-4650-8cf0-2c0685b51531" href="/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device" title="How to Determine if Your Product is a Medical Device">medical device</a>, the product must also comply with the medical device regulations.</p> <h2><a id="link_1" name="link_1"></a>Definition of Electronic Product Radiation</h2> <p>Manufacturers and distributors of products meeting the definition of "electronic product radiation" in section 531 of the <a href="/federal-food-drug-and-cosmetic-act-fdc-act">Federal Food Drug & Cosmetic (FD&C) Act</a> may be subject to certain provisions of the FD&C Act including the retention of records and submission of product reports to the FDA, specifically to the Center for Devices and Radiological Health (CDRH). The FDA requirements for these products, record keeping and reporting, are included in the final regulations contained in Title 21 Code of Federal Regulations Parts 1000-1050 (<a href="https://www.ecfr.gov/">21 CFR 1000 - 1050</a>). According to section 531 of the FD&C Act:</p> <ol> <li>the term "electronic product radiation" means - <ol type="A"> <li>any ionizing or non-ionizing electromagnetic or particulate radiation, or</li> <li>any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;</li> </ol> </li> <li>the term "electronic product" means <ol type="A"> <li>any manufactured or assembled product which, when in operation, <ol type="i"> <li>contains or acts as part of an electronic circuit and</li> <li>emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or</li> </ol> </li> <li>any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;</li> </ol> </li> <li>the term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products.</li> </ol> <p>Most radiation-emitting products are not considered to be <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="581080c0-3afb-4650-8cf0-2c0685b51531" href="/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device" title="How to Determine if Your Product is a Medical Device">medical devices</a>. However, if you make any medical claims, your product is a medical device also subject to the provisions of the FD&C Act for medical devices in addition to the provisions for radiation emitting products.</p> <h2><a id="link_2" name="link_2"></a>Examples of Electronic Products</h2> <p>Examples of radiation emitting electronic products subject to the provisions of the FD&C Act and therefore regulated by FDA are listed in <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1000/subpart-B/section-1000.15">21 CFR 1000.1</a> and include:</p> <ol> <li><strong>Ionizing electromagnetic radiation: </strong> <ul> <li>Television receivers</li> <li>Accelerators</li> <li>X-ray machines (industrial, medical, research, educational)</li> </ul> </li> <li><strong>Particulate radiation and ionizing electromagnetic radiation: </strong> <ul> <li>Electron microscopes</li> <li>Neutron generators</li> </ul> </li> <li><strong>Ultraviolet: </strong> <ul> <li>Biochemical and medical analyzers</li> <li>Tanning and therapeutic lamps</li> <li>Sanitizing and sterilizing devices</li> <li>Black light sources</li> <li>Welding equipment</li> </ul> </li> <li><strong>Visible:</strong> <ul> <li>White light devices</li> </ul> </li> <li><strong>Infrared: </strong> <ul> <li>Alarm systems</li> <li>Diathermy units</li> <li>Dryers, ovens, and heaters</li> </ul> </li> <li><strong>Microwave:</strong> <ul> <li>Alarm systems</li> <li>Diathermy units</li> <li>Dryers, ovens, and heaters</li> <li>Medico-biological heaters</li> <li>Microwave power generating devices</li> <li>Radar devices</li> <li>Remote control devices</li> <li>Signal generators</li> </ul> </li> <li><strong>Radio and low frequency: </strong> <ul> <li>Cauterizers</li> <li>Diathermy units</li> <li>Power generation and transmission equipment</li> <li>Signal generators</li> <li>Electromedical equipment</li> </ul> </li> <li><strong>Laser:</strong> <ul> <li>Art-form, experimental and educational devices</li> <li>Biomedical analyzers</li> <li>Cauterizing, burning and welding devices</li> <li>Cutting and drilling devices</li> <li>Communications transmitters</li> <li>Range finding devices</li> </ul> </li> <li><strong>Maser: </strong> <ul> <li>Communications transmitters.</li> </ul> </li> <li><strong>Infrasonic:</strong> <ul> <li>Vibrators</li> </ul> </li> <li><strong>Sonic:</strong> <ul> <li>Electronic oscillators</li> <li>Sound amplification equipment</li> </ul> </li> <li><strong>Ultrasonic:</strong> <ul> <li>Cauterizers</li> <li>Cell and tissue disintegrators</li> <li>Cleaners</li> <li>Diagnostic and nondestructive testing equipment</li> <li>Ranging and detection equipment</li> </ul> </li> </ol> <h2><a id="link_3" name="link_3"></a>Record and Reporting Requirements by Product</h2> <h4>Certain radiation emitting products require the submission of product reports to FDA and the retention of records as included in 21 CFR <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=1002">Part 1002</a> and Table I that follows.</h4> <p><strong>Note:</strong> All manufacturers of electronic products are subject to the reporting of accidental radiation occurrences, as required by 21 CFR <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.20">1002.20</a>.</p> <h4 class="text-center">Table I - Record and Reporting Requirements By Product</h4> <div class="table-responsive"><tdx td> </tdx> <table class="table text-center align-top table-bordered table-condensed" summary="Record and Reporting Requirements By Product"> <thead> <tr> <th class="text-center" colspan="8" scope="col"><strong>Manufacturer</strong></th> <th scope="col"><strong>Dealer &<br> Distributor</strong></th> </tr> <tr> <th scope="col"><strong>Product Category</strong></th> <th scope="col"><strong>Products</strong></th> <th scope="col"><strong>Product<br> reports<br> Section<br> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.10">1002.10</a></strong></th> <th scope="col"><strong>Supplemental<br> reports<br> Section<br> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.11">1002.11</a></strong></th> <th scope="col"><strong>Abbreviated<br> reports<br> Section<br> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.12">1002.12</a></strong></th> <th scope="col"><strong>Annual<br> reports<br> Section<br> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.13">1002.13</a></strong></th> <th scope="col"><strong>Test<br> records<br> Section<br> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.30">1002.30</a><br> (a)<sup>1</sup></strong></th> <th scope="col"><strong>Distribution<br> records<br> Section<br> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.30">1002.30</a><br> (b)<sup>2</sup></strong></th> <th scope="col"><strong>Distribution<br> records<br> Sections<br> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.40">1002.40</a><br> and <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.41">1002.41</a></strong></th> </tr> </thead> <tbody> <tr> <td rowspan="12"><strong>DIAGNOSTIC X-RAY<sup>3</sup> (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.30">1020.30</a>, <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.31">1020.31</a>, <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.32">1020.32</a>, <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.33">1020.33</a>)</strong></td> <td>Computed tomography</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>X-ray system<sup>4</sup></td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>Tube housing assembly</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td>X-ray control</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>X-ray high voltage generator</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>X-ray table or cradle</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>X-ray film changer</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td>Vertical cassette holders mounted in a fixed location and cassette holders with front panels</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>Beam-limiting devices</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>Spot-film devices and image intensifiers manufactured after April 26, 1977</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>Cephalometric devices manufactured after February 25, 1978</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td>Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td rowspan="2"><strong>CABINET X-RAY (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.40">1020.40</a>)</strong></td> <td>Baggage inspection</td> <td>X</td> <td>X</td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>Other</td> <td>X</td> <td>X</td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td rowspan="3"><strong>PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY</strong></td> <td>Medical</td> <td> </td> <td> </td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td>Analytical</td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td>Industrial</td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td rowspan="2"><strong>TELEVISION PRODUCTS (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.10">1020.10</a>)</strong></td> <td><0.1 milliroentgen="" per="" hour="" (mR/hr=""><sup>5,6</sup></td> <td> </td> <td> </td> <td>X<sup>8</sup></td> <td>X<sup>6</sup></td> <td> </td> <td> </td> <td> </td> </tr> <tr> <td>>=0.1mR/hr IRLC<sup>5</sup></td> <td>X<sup>8</sup></td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td rowspan="4"><strong>MICROWAVE/RF</strong></td> <td>MW ovens (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1030.10">1030.10</a>)</td> <td>X<sup>8</sup></td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td>MW diathermy</td> <td> </td> <td> </td> <td>X</td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr> <td>MW heating, drying, security systems</td> <td> </td> <td> </td> <td>X</td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr> <td>RF sealers, electromagnetic induction and heating equipment, di-electric heaters (2-500 megahertz)</td> <td> </td> <td> </td> <td>X</td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr> <td><strong>OPTICAL</strong></td> <td>Phototherapy products</td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr> <td rowspan="4"><strong>Laser products (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.10">1040.10</a>, <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.11"> 1040.11</a>)</strong></td> <td>Class I lasers and products containing lasers<sup>7,9</sup></td> <td>X<sup>8</sup></td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td> </td> <td> </td> </tr> <tr> <td>Class I laser products containing class IIa, II, IIIa, lasers<sup>7,9</sup></td> <td>X</td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td> </td> </tr> <tr> <td>Class IIa, II, IIIa lasers and products other than class I products containing such lasers<sup>7,9</sup></td> <td>X</td> <td> </td> <td> </td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td>Class IIIb and IV lasers and products containing such lasers<sup>7</sup></td> <td>X</td> <td>X</td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td rowspan="2"><strong>Sunlamp products (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.20">1040.20</a>)</strong></td> <td>Lamps only</td> <td>X</td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> <tr> <td>Sunlamp products</td> <td>X</td> <td>X</td> <td> </td> <td>X</td> <td>X</td> <td>X</td> <td>X</td> </tr> <tr> <td><strong>Mercury vapor lamps (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.30">1040.30</a>)</strong></td> <td>R and T lamps</td> <td> </td> <td> </td> <td>X</td> <td> </td> <td> </td> <td> </td> <td> </td> </tr> </tbody> </table> </div> <p><sup>1</sup>However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.<br> <sup>2</sup>The requirement includes <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.31">1002.31</a> and <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.42">1002.42</a>, if applicable.<br> <sup>3</sup>Report of Assembly (<a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="41aa2346-1c33-4025-b0c6-e0db744ee4ab" href="/about-fda/reports-manuals-forms/forms" title="Forms">Form FDA 2579</a>) is required for diagnostic x-ray components; see 21 CFR <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.30">1020.30</a>(d)(1) through (d)(3).<br> <sup>4</sup>Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.30">1020.30</a>(c).<br> <sup>5</sup>Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.10">1020.10</a>(c)(3)(iii)).<br> <sup>6</sup>Annual report is for production status information only.<br> <sup>7</sup>Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.<br> <sup>8</sup>Manufacturers are exempt from product reports (搂 <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1002.10">1002.10</a>) and abbreviated reports (搂 <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1002.12">1002.12</a>), except the first product or abbreviated report for each category of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance, service, or failure (e.g., Class I optical disc products, laser printers).<br> <sup>9</sup>Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1010.2">1010.2</a>(e) are considered distributors of the certified laser and only subject to the applicable distribution recordkeeping requirements under 搂搂 <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1002.40">1002.40</a> and <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1002.41">1002.41</a> for the certified products.</p>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2023-02-21T09:37:00Z">02/21/2023</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Medical Devices</li> <li role="menuitem">Radiation-Emitting Products</li> </ul> <h2 class="lcds-description-list__item-heading">Topic(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">FDA Activities</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav"class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/medical-devices/overview-device-regulation/classify-your-medical-device" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link"> Classify Your Medical Device </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-2e1867f8f9bbfeac6e7251bcf34272cf2706789a81e92b3b0af640a9cd1b401e"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/medical-devices/classify-your-medical-device/does-product-emit-radiation" class="lcds-section-nav__link lcds-section-nav--side__link">Does the Product Emit Radiation?</a></li> <li><a href="/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device" class="lcds-section-nav__link lcds-section-nav--side__link">How to Determine if Your Product is a Medical Device</a></li> <li><a href="/medical-devices/classify-your-medical-device/medical-device-accessories" class="lcds-section-nav__link lcds-section-nav--side__link">Medical Device Accessories</a></li> <li><a href="/medical-devices/classify-your-medical-device/device-classification-panels" class="lcds-section-nav__link lcds-section-nav--side__link">Device Classification Panels</a></li> <li><a href="/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions" class="lcds-section-nav__link lcds-section-nav--side__link">Class I and Class II Device Exemptions </a></li> <li><a href="/medical-devices/classify-your-medical-device/product-code-classification-database" class="lcds-section-nav__link lcds-section-nav--side__link">Product Code Classification Database</a></li> <li><a href="/medical-devices/classify-your-medical-device/reclassification" class="lcds-section-nav__link lcds-section-nav--side__link">Reclassification</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-f09d8f518f58d8465d5ed5025a8616af8e23da9386d618cc5b8090a83076151e"> </div> </div> </li> </ul> </nav> </div> </section> </aside> </article> </main> </div> </div> <div class="region region-subscribe"> <section id="block-entityviewcontent-5" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> </section> </div> <footer class="lcds-footer container-fluid"> <div class="row lcds-footer__primary"> <h2 id="footer-heading" class="sr-only">Footer Links</h2> <nav class="text-center"> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/about-website/fdagov-archive" >FDA Archive</a></li> <li><a href="/about-fda" >About FDA</a></li> <li><a href="/about-fda/about-website/internet-accessibility" >Accessibility</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/visitor-information" >Visitor Information</a> </li> <li><a href="/about-fda/about-website/website-policies" >Website Policies / Privacy</a></li> <li><a href="/about-fda/jobs-and-training-fda/no-fear-act" >No FEAR Act</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" >Vulnerability Disclosure Policy</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/regulatory-information/freedom-information" title="Freedom of Information Act">FOIA</a></li> <li><a href="https://www.hhs.gov/" title="Health and Human Services" target="_blank">HHS.gov</a></li> <li><a href="https://www.usa.gov/" target="_blank">USA.gov</a></li> </ul> </div> </nav> </div> <div class="row lcds-footer__secondary"> <div class="col-sm-12 col-md-6 col-lg-4 lcds-footer__social-links"> <a href="/about-fda/contact-fda" class="btn btn-default btn-md">Contact FDA</a> <a href="https://www.facebook.com/FDA" title="Follow FDA on Facebook" class="no-disclaimer"> <span class="fa fa-facebook fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Facebook</span> </span> </a> <a href="https://x.com/US_FDA" title="Follow FDA on X" class="no-disclaimer"> <svg class="icon-svg-inline fa-2x" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> <span class="sr-only">Follow FDA on X</span> </a> <a href="https://instagram.com/FDA" title="Follow FDA on Instagram" class="no-disclaimer"> <span class="fa fa-instagram fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Instagram</span> </span> </a> <br class='visible-xs-inline'/> <a href="https://www.linkedin.com/company/fda/" title="Follow FDA on LinkedIn" class="no-disclaimer"> <span class="fa fa-linkedin fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on LinkedIn</span> </span> </a> <a href="https://youtube.com/@US_FDA" title="View FDA videos on YouTube" class="no-disclaimer"> <span class="fa fa-youtube fa-2x" aria-hidden="true"> <span class="sr-only">View FDA videos on YouTube</span> </span> </a> <a href="/about-fda/contact-fda/subscribe-podcasts-and-news-feeds" title="Subscribe to FDA RSS feeds"> <span class="fa fa-rss fa-2x" aria-hidden="true"> <span class="sr-only">Subscribe to FDA RSS feeds</span> </span> </a> </div> <a href="/" title="FDA Homepage"> <div class="visible-lg-block col-lg-4 text-center lcds-footer__logo"> <span class="sr-only">FDA Homepage</span> </div> </a> <div class="col-sm-12 col-md-6 col-lg-4 text-center lcds-footer__contact-number"> <span class="fa fa-phone" aria-hidden="true"> </span> <span class="sr-only">Contact Number</span> 1-888-INFO-FDA (1-888-463-6332) </div> </div>  </footer> <a href="" id="btn-top" class="btn btn-primary btn-top"><span class="sr-only">Back to </span>Top</a> </div> <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/354185","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"fda_ckeditor_enhancements":{"basePath":"modules\/custom\/fda_ckeditor_enhancements"},"google_analytics":{"account":"G-273DTKB5QW","trackOutbound":true,"trackMailto":true,"trackTel":true,"trackDownload":true,"trackDownloadExtensions":"7z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip"},"bootstrap":{"forms_has_error_value_toggle":1,"modal_animation":1,"modal_backdrop":"true","modal_focus_input":1,"modal_keyboard":1,"modal_select_text":1,"modal_show":1,"modal_size":"","popover_enabled":1,"popover_animation":1,"popover_auto_close":1,"popover_container":"body","popover_content":"","popover_delay":"0","popover_html":0,"popover_placement":"right","popover_selector":"","popover_title":"","popover_trigger":"click"},"ajax":[],"user":{"uid":0,"permissionsHash":"3aef67b4ac7d861d8624bf1f7ab2bc9cfc56d3c25b7d709dc15466dfa996dfb0"}}</script> <script src="/files/js/js_jmx6639WuKcEs1DgFSmm8g__5ByGF4YtLnPWvZO-XrM.js?scope=footer&delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A"></script> <script type="text/javascript" src="/Dc2Go5/dCelR/Sewog/rk5-/5VYNNfD46DcX/DQdKdDY/XS/EsHSMaAwQB"></script></body> </html>

CINXE.COM

Does the Product Emit Radiation? | FDA