Market shape

Where the FDA-cleared listing universe clusters

Buyer friction signals

Pricing is unknown or not publicly available for 1230 listings. Deployment is unknown or not publicly available for 570 listings. Exact product purpose is curated for 1230 listings; implementation evidence is curated for 1167; exact-version performance metrics are curated for 410 products.

Buyers can use these gaps to shape vendor demos and RFP questions. Vendors can improve their public profile by correcting exact-version data with source-backed documentation.

Open comparison workspace

Recent FDA-cleared listings

Newest decisions in the dataset

FDA-cleared K253969

ADAS 3D

Adas3D Medical S.L.

ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart; myocardial scar and cardiac structures
Decision
2026-06-29
FDA-cleared K260667

Alturion Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; ophthalmic; urologic organs; and lung
Decision
2026-06-29
FDA-cleared K260714

MammoScreen® (5)

Therapixel

Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-06-26
FDA-cleared K253786

syngo.CT Coronary Cockpit

Siemens Medical Solutions USA, Inc.

An extension for syngo.via that assists trained physicians with automated and semi-automated analysis, visualization and reporting of cardiac CT angiography volume datasets for...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2026-06-25
FDA-cleared K253560

Enhanced Boundary for PCCT

Ge Medical Systems, LLC

Enhanced Boundary for PCCT is a deep-learning CT processing function for improved soft-tissue delineation in routine head examinations with or without contrast.

Modality
CT/CTA
Anatomy
Head
Decision
2026-06-24