Device database
AI-enabled devices on the FDA list
1,614 submission rows from the FDA list retrieved October 23, 2026. Filters run in the browser. Each row links to the official FDA database entry.
Newest on the list
June 29, 2026 · Radiology
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)K253628 · Agada Medical, Ltd.
June 29, 2026 · Radiology
ADAS 3DK253969 · Adas3D Medical S.L.
June 29, 2026 · Radiology
Alturion Series Diagnostic Ultrasound SystemK260667 · Philips Ultrasound, LLC
June 27, 2026 · Neurology
SOMNUM (SOMNUM)K253390 · Honeynaps Co., Ltd.
June 26, 2026 · Radiology
MammoScreen® (5)K260714 · Therapixel
June 25, 2026 · Radiology
syngo.CT Coronary CockpitK253786 · Siemens Medical Solutions USA, Inc.
June 24, 2026 · Radiology
Enhanced Boundary for PCCTK253560 · Ge Medical Systems, LLC
June 22, 2026 · Anesthesiology
RX-1 SleepK253148 · Vivaquant, Inc. Dba Rhythm Express
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