510(k)K253628
Directory
FDA AI Clearance Tracker
Every FDA-authorized AI-enabled medical device we can search, in one place. Filter by specialty, company and pathway. Built from the FDA's public list.
Devices listed
1,614
from 816 companies
Top specialties
- 1,230
- 154
- 73
- 30
- 27
Pathway
- 1,553 · 96%
- 40 · 2%
- 21 · 1%
Recent clearances
June 2026
510(k)K253969
510(k)K260667
510(k)K253390
510(k)K260714
510(k)K253786
510(k)K253560
510(k)K253148
510(k)K260316
510(k)K253050
510(k)K260190
510(k)K260729
Search the full list
1,614 devices
510(k)K253628
510(k)K253969
510(k)K260667
510(k)K253390
510(k)K260714
510(k)K253786
510(k)K253560
510(k)K253148
510(k)K260316
510(k)K253050
510(k)K260190
510(k)K260729
510(k)K261713
Radiology · Jun 16, 2026
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
510(k)K260844
510(k)K253172
510(k)K253690
510(k)K253825
510(k)K260300
510(k)K260406
Radiology · Jun 11, 2026
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
510(k)K260322
510(k)K253192
510(k)K260332
510(k)K253984
510(k)K260497
510(k)K261519
510(k)K260402
510(k)K260780
510(k)K252844
510(k)K252859
510(k)K252947
510(k)K260077
Gastroenterology-Urology · May 29, 2026
GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
Cosmo Artificial Intelligence - Ai, Ltd.
510(k)K261369
510(k)K261405
510(k)K254075
510(k)K260123
Radiology · May 27, 2026
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
510(k)K260680
De NovoDEN250057
510(k)K260113
Radiology · May 22, 2026
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Canon Medical Informatics, Inc.
510(k)K260324
De NovoDEN250028
Radiology · May 21, 2026
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Wuhan United Imaging Healthcare Co.,Ltd
510(k)K253720
510(k)K254131
510(k)K260234
510(k)K253596
510(k)K250781
510(k)K252563
Radiology · May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super
Wuhan United Imaging Healthcare Co.,Ltd
510(k)K253716
510(k)K254120
510(k)K261273
510(k)K261289
510(k)K254013
510(k)K261317
510(k)K260032
510(k)K260378
510(k)K252953
510(k)K260419
510(k)K253992
510(k)K252558
510(k)K252954
510(k)K254115
Source: U.S. FDA AI-Enabled Medical Devices list. Latest decision in the data: Jun 29, 2026. Data loaded October 29, 2026.
The FDA says this list is not comprehensive, so some authorized AI-enabled devices may not appear here. Always confirm details on the FDA's own records.