{"abstract":"The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.","action":"Final amendment; final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2020/01/22/2020-00494.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"892","title":21}],"citation":"85 FR 3545","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective February 21, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-1553"],"dockets":[],"document_number":"2020-00494","effective_on":"2020-02-21","end_page":3548,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/01/22/2020-00494.xml","html_url":"https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-00494?publication_date=2020-01-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-01-22/2020-00494/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":8505,"last_updated":"2026-10-28 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-01-22/pdf/2020-00494.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-00494.pdf?1579614316","publication_date":"2020-01-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/01/22/2020-00494.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-1553","supporting_documents_count":0,"docket_id":"FDA-2018-N-1553","regulation_id_number":null,"title":"Radiology Devices; Reclassification of Medical Image Analyzers ","checked_regulationsdotgov_at":"2020-04-12T03:30:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3545,"subtype":null,"title":"Radiology Devices; Reclassification of Medical Image Analyzers","toc_doc":"Reclassification of Medical Image Analyzers","toc_subject":"Radiology Devices:\n","topics":["Medical devices","Radiation protection","X-rays"],"type":"Rule","volume":85}