FDA-cleared radiology AI tools | Source-backed directory

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Confirm the FDA file number and decision date before interpreting marketing claims.
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Representative FDA-backed listings

Start with a balanced cross-modality sample

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

Breast imaging

FDA-cleared K153351

Quantib Brain 1

QUANTIB BV

Quantib Brain is post-processing analysis software for the GE Advantage (AW 4.7) or AW Server (AWS

Modality: MRI
Anatomy: Brain
Decision: 2016-06-17

Quantification and segmentation Neuro MRI

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

Fluoroscopy/Angiography workflow

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

Chest CT

FDA-approved P150043

QVCAD System

QView Medical, Inc.

Image analysis/processing

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: N/A
Decision: 2016-11-09

Radiological images; modality varies or is not specified in FDA list workflow

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

Ultrasound workflow

FDA-authorized DEN180005