id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2025-P-5560-0023,FDA,FDA-2025-P-5560,Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices,Notice,Announcement,2025-12-29T05:00:00Z,2025,12,2025-12-29T05:00:00Z,2026-02-28T04:59:59Z,2026-02-28T10:00:12Z,2025-23901,0,0,09000064b910a2ff
FDA-2025-P-5560-0019,FDA,FDA-2025-P-5560,"Larson, P. A. (2014). Actionable Findings and the Role of IT Support: Report of the ACR Actionable Reporting Work Group",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:44:19Z,,0,0,09000064b9056f7f
FDA-2025-P-5560-0008,FDA,FDA-2025-P-5560,"Asin, S. (2024, December 31). The radiologist shortage, explained",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:42:56Z,,0,0,09000064b90564f9
FDA-2025-P-5560-0014,FDA,FDA-2025-P-5560,"Dreyer, K. (2024, November 20). U.S. Food and Drug Administration",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:33Z,,0,0,09000064b9056d79
FDA-2025-P-5560-0001,FDA,FDA-2025-P-5560,"Citizen Petition from Rubrum Advising, LLC",Other,Citizen Petition,2025-10-28T04:00:00Z,2025,10,2025-10-28T04:00:00Z,,2026-02-20T20:29:49Z,,1,0,09000064b904d129
FDA-2025-P-5560-0018,FDA,FDA-2025-P-5560,"Jing, A. G. (2025, October 24). AI solutions to the radiology workforce shortage. npj Health Systems, 2(20), 1-6",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:44:15Z,,0,0,09000064b9056f7e
FDA-2025-P-5560-0012,FDA,FDA-2025-P-5560,"Coleman, K. a. (2025, September). Targeted Postmarket Surveillance: The Way Toward Responsible AI Innovation in Health Care",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:22Z,,0,0,09000064b9056d77
FDA-2025-P-5560-0006,FDA,FDA-2025-P-5560,American College of Radiology. (n.d.-c.). AI Use Cases: Pneumonia,Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:42:52Z,,0,0,09000064b90564f7
FDA-2025-P-5560-0007,FDA,FDA-2025-P-5560,American College of Radiology. (n.d.-d.). Performance Monitoring (Assess-AI),Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:42:54Z,,0,0,09000064b90564f8
FDA-2025-P-5560-0021,FDA,FDA-2025-P-5560,Radboud University Medical Center. (2025). Grand Challenge,Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:44:32Z,,0,0,09000064b9056f81
FDA-2025-P-5560-0002,FDA,FDA-2025-P-5560,"Acknowledgement Letter from FDA DMB to Rubrum Advising, LLC",Other,Acknowledgement Letter/Receipt,2025-10-28T04:00:00Z,2025,10,2025-10-28T04:00:00Z,,2025-10-28T23:41:18Z,,0,0,09000064b904d12a
FDA-2025-P-5560-0004,FDA,FDA-2025-P-5560,American College of Radiology. (n.d.-a.). ACR Recognized Center for Healthcare-AI (ARCH-AI),Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:42:46Z,,0,0,09000064b90564f5
FDA-2025-P-5560-0022,FDA,FDA-2025-P-5560,"Salian, I. (2021, March 25). NIH, NVIDIA Use AI to Trace COVID-19 Disease Progression in Chest CT Images",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:44:35Z,,0,0,09000064b9056f82
FDA-2025-P-5560-0003,FDA,FDA-2025-P-5560,"Alarcon, N. (2020, February 28). AI Helps Doctors Diagnose the Coronavirus",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:42:39Z,,0,0,09000064b90564ee
FDA-2025-P-5560-0015,FDA,FDA-2025-P-5560,European Commission. (n.d.). EUDAMED - European Database on Medical Devices,Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:36Z,,0,0,09000064b9056f7a
FDA-2025-P-5560-0009,FDA,FDA-2025-P-5560,"Behzad, S., Tabatabaei, S. M., Lu, M. Y., Eibschutz, L. S., & Gholamrezanezhad, A. (2024, July 24). Pitfalls in Interpretive Applications of Artificial Intelligence in Radiology",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:15Z,,0,0,09000064b90564fa
FDA-2025-P-5560-0013,FDA,FDA-2025-P-5560,CTA. (2025). Performance Verification and Validation for Predictive Health AI Solutions (CTA-2135),Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:30Z,,0,0,09000064b9056d78
FDA-2025-P-5560-0016,FDA,FDA-2025-P-5560,"Gonzalez, N. (2025, February 12). New Studies Shed Light on the Future Radiologist Workforce Shortage by Projecting Future Radiologist Supply and Demand for Imaging",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:39Z,,0,0,09000064b9056f7b
FDA-2025-P-5560-0017,FDA,FDA-2025-P-5560,"Hillis JM, V. J. (2024, Mar 15). The lucent yet opaque challenge of regulating artificial intelligence in radiology",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:50Z,,0,0,09000064b9056f7d
FDA-2025-P-5560-0020,FDA,FDA-2025-P-5560,"Obuchowski, N. A. (2022, April 1). Multireader Diagnostic Accuracy Imaging Studies: Fundamentals of Design and Analysis. Radiology, 303(1), 26-34",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:44:21Z,,0,0,09000064b9056f80
FDA-2025-P-5560-0005,FDA,FDA-2025-P-5560,American College of Radiology. (n.d.-b.). AI Central,Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:42:49Z,,0,0,09000064b90564f6
FDA-2025-P-5560-0010,FDA,FDA-2025-P-5560,"Boon, M. (2025, January 15). Addressing Pathologist Shortages: AI’s Role in Modern Diagnostics",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:17Z,,0,0,09000064b9056d75
FDA-2025-P-5560-0011,FDA,FDA-2025-P-5560,"Candelon, F. G. (2021, June 4). China’s response to COVID showed the world how to make the most of A.I.",Supporting & Related Material,Background Material,2025-10-28T04:00:00Z,2025,10,,,2025-10-28T23:43:20Z,,0,0,09000064b9056d76