Market shape

Where the FDA-backed listing universe clusters

Buyer friction signals

Pricing is unknown or not publicly available for 1079 listings. Deployment is unknown or not publicly available for 419 listings. Integration language is publicly available for 1072 listings.

This is the directory's first defensible content wedge: buyers need practical procurement fields, and vendors can improve their public profile by correcting exact-version data.

Recent FDA-backed listings

Newest decisions in the dataset

FDA-cleared K252379

AIR Recon DL

Ge Medical Systems, LLC

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-12-23
FDA-cleared K250959

BioticsAI

Bioticsai, Inc.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2025-12-22
FDA-cleared K252856

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2025-12-22