FDA source first
Profiles start with FDA file numbers, decision dates, and public source links before vendor claims are summarized.
Public beta - FDA-cleared radiology AI directory
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.
How to use it
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
Methodology
Profiles start with FDA file numbers, decision dates, and public source links before vendor claims are summarized.
FDA status is treated as regulatory context, not as clinical, procurement, security, billing, or performance advice.
Pricing, deployment, integration, and evidence gaps remain labeled unknown until public sources or exact-version documentation support an update.
Vendors and readers can submit source-backed corrections through a visible workflow tied to each profile.
Balanced sample
Matakina Technology LTD
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis.
QUANTIB BV
Quantib Brain is post-processing analysis software for the GE Advantage (AW 4.7) or AW Server (AWS
Cydar Ltd.
Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery.
RIVERAIN TECHNOLOGIES, LLC
ClearRead CT provides adjunctive information and is not intended to be used without the o.
QView Medical, Inc.
Image analysis/processing
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)
Imagen Technologies, Inc.
Computer-aided detection/diagnosis
Mirada Medical Ltd.
Image analysis/processing.
Zebra Medical Vision Ltd.
Image analysis/processing.