U.S. radiology AI buyer directory

Find FDA-backed radiology AI tools by modality, use case, vendor, and workflow fit.

Built from the cleaned FDA radiology AI dataset in this workspace. Each listing keeps regulatory source links, decision dates, unknowns, and correction paths visible.

Listings 1079
Vendors 493
Modalities 11
Use cases 19
Latest FDA decision in dataset: 2025-12-30

Launch taxonomy

Explore the market from the buyer's first question

Balanced launch sample

Representative listings across modalities

FDA-cleared K153427

Volpara Imaging Software

Matakina Technology LTD

Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2016-01-07
FDA-cleared K160088

Cydar EV

Cydar Ltd.

Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery.

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2016-07-07
FDA-cleared K161201

ClearRead CT

RIVERAIN TECHNOLOGIES, LLC

ClearRead CT provides adjunctive information and is not intended to be used without the o.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2016-09-09
FDA-cleared K163138

Clarius Ultrasound System

Clarius Mobile Health Corp.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3)

Modality
Ultrasound
Anatomy
N/A
Decision
2016-11-30
FDA-cleared K181572

Workflow Box

Mirada Medical Ltd.

Image analysis/processing.

Modality
Radiotherapy planning imaging
Anatomy
N/A
Decision
2018-07-10