Public beta - FDA-cleared radiology AI directory

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

A source-linked Parikh Radiology directory for comparing radiology AI solutions with FDA decision details, public evidence links, buyer-fit caveats, and correction paths kept visible.

Listings 1079
Vendors 493
Modalities 11
Use cases 19
Latest FDA decision in dataset: 2025-12-30
Dataset last verified: April 28, 2026

How to use it

Start with regulatory traceability, then verify workflow fit.

Use the directory to build a shortlist, compare practical unknowns, and open the source ledger before contacting vendors. Final clinical, operational, security, billing, and purchasing decisions still need local review.

Directory taxonomy

Explore the market from the buyer's first question

Methodology

Built to keep trust signals near the data

FDA source first

Profiles start with FDA file numbers, decision dates, and public source links before vendor claims are summarized.

Clearance is not endorsement

FDA status is treated as regulatory context, not as clinical, procurement, security, billing, or performance advice.

Unknowns stay visible

Pricing, deployment, integration, and evidence gaps remain labeled unknown until public sources or exact-version documentation support an update.

Corrections are welcomed

Vendors and readers can submit source-backed corrections through a visible workflow tied to each profile.

Balanced 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