Live indexLIVE INDEX · Last updated Oct 11, 2026 · 1,614 devices · updated weekly

Every FDA-listed AI medical device, in one live index.

FDA's AI-enabled device list joined to openFDA records and patent context, checked join by join, and updated weekly.

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Explore: Browse all 1,614 devices · Example device page · How we build it · Updates

Recently added to FDA's list

The index moves when FDA does.

Updated weekly. These are the newest decisions in the current dataset (FDA list through Jun 29, 2026; dataset rebuilt Oct 11, 2026).

Changelog Oct 11, 2026: v1 build · 1,614 devices · 1,614 of 1,614 matched to openFDA · 1,553 510(k), 40 De Novo, 21 PMA/PMA supplement
  1. Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd. · K253628 · 510(k) · Radiology
  2. ADAS 3DAdas3D Medical S.L. · K253969 · 510(k) · Radiology
  3. Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · K260667 · 510(k) · Radiology
  4. SOMNUM (SOMNUM)Honeynaps Co., Ltd. · K253390 · 510(k) · Neurology
  5. MammoScreen® (5)Therapixel · K260714 · 510(k) · Radiology
  6. syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · K253786 · 510(k) · Radiology
From the patent record

Real devices in the index, as their inventors drew them.

US patent drawing, US 8,315,812 B2
HeartFlow Analysis · HeartFlow, Inc. · FDA K250902Patent drawing US 8,315,812 B2, HeartFlow, Inc., via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version.
US patent drawing, US 7,474,775 B2
IDx-DR v2.3 · Digital Diagnostics Inc. · FDA K213037Patent drawing US 7,474,775 B2, University of Iowa Research Foundation (inventors incl. Michael D. Abràmoff), via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version.
US patent drawing, US 9,973,847 B2
Eko Foundation Analysis Software with Transformers (EFAST) · Eko Health, Inc. · FDA K251494Patent drawing US 9,973,847 B2, Eko Devices, Inc. (now Eko Health, Inc.), via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version.
US patent drawing, US 11,432,766 B2
Hypertension Notification Feature (HTNF) · Apple Inc. · FDA K250507Patent drawing US 11,432,766 B2, Apple Inc., via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version.
Illustration of generic AI-enabled medical devices
Illustration. Generic device types (ultrasound probe, stethoscope, wearable, retinal camera), not any specific company's product.
What's in a row

Pathway, review time, product code, class.

Each FDA entry joined to openFDA so you can sort ultrasound from ECG from retinal imaging in seconds.

What you get

01

Joined & checked

Every device matched to openFDA records; mismatches flagged, not hidden.

02

Updated weekly

New FDA decisions land in the index with a public changelog.

03

Documented fields

A data dictionary and method notes for every column.

EXAMPLE PLACEHOLDER — NOT A REAL TESTIMONIALReader quotes and logos appear here only once real, permissioned ones exist.

Every FDA-listed AI medical device, in one live index.

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