Detection and CADe radiology AI tools | Buyer shortlist

FDA-cleared K161382

LVivo Software Application

DIACARDIO, LTD.

LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...

Modality: MRI
Anatomy: Heart
Decision: 2016-07-28

Cardiac imaging Detection and CADe Quantification and segmentation

FDA-cleared K161959

ClearView cCAD

ClearView Diagnostics Inc.

earView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.

Modality: Ultrasound
Anatomy: Breast
Decision: 2016-12-28

Breast imaging Detection and CADe Ultrasound workflow

FDA-authorized DEN170022

QuantX

Quantitative Insights, Inc

Computer-aided detection/diagnosis

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: N/A
Decision: 2017-07-19

Detection and CADe

FDA-authorized DEN180005

OsteoDetect

Imagen Technologies, Inc.

Computer-aided detection/diagnosis

Modality: PET/SPECT/Nuclear Medicine
Anatomy: N/A
Decision: 2018-05-24

Detection and CADe Nuclear medicine

FDA-approved P200003

Imagio Breast Imaging System

Seno Medical Instruments, Inc.

Computer-aided detection/diagnosis

Modality: Modality not specified in FDA list
Anatomy: Breast
Decision: 2021-01-11

Breast imaging Detection and CADe

FDA-authorized DEN220040

Fibresolve

Imvaria, Inc

Computer-aided detection/diagnosis

Modality: Radiotherapy planning imaging
Anatomy: N/A
Decision: 2024-01-12

Radiotherapy planning Detection and CADe

FDA-authorized DEN230023

Rho

16 Bit Inc

Computer-aided detection/diagnosis

Modality: Modality not specified in FDA list
Anatomy: N/A
Decision: 2024-04-09

Detection and CADe

FDA-approved P140011/S008

MAMMOMAT B.brilliant with Tomosynthesis Option

SIEMENS MEDICAL SOLUTIONS USA, INC.

Computer-aided detection/diagnosis

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-09-23

Breast imaging Detection and CADe

FDA-authorized DEN240047

Allix5

Clairity, Inc.

Computer-aided detection/diagnosis

Modality: Modality not specified in FDA list
Anatomy: N/A
Decision: 2025-05-30

Detection and CADe