Radiology AI Directory

Vendor

Clarius Mobile Health Corp.

11 FDA-backed listings in this directory.

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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-cleared K172385

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) BM Color...

Modality
Ultrasound
Anatomy
Abdomen
Decision
2017-09-14
Ultrasound workflow
FDA-cleared K222406

Clarius AI

Clarius Mobile Health Corp.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-01-23
CT/CTA workflow
FDA-cleared K233955

Clarius OB AI

Clarius Mobile Health Corp.

Image analysis/processing.

Modality
Ultrasound
Anatomy
N/A
Decision
2024-06-14
Ultrasound workflow
FDA-cleared K243853

Clarius Prostate AI

Clarius Mobile Health Corp.

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2025-04-16
Prostate imaging