FDA-cleared K240417

ProFound Detection (V4.0)

iCAD, Inc.

Concurrent CAD/CADx aid for interpreting physicians reading compatible DBT exams to detect soft-tissue densities and calcifications for physician confirmation or dismissal.

Modality
Mammography/DBT
Anatomy
Breast.
Decision
2024-11-08
FDA-cleared K211506

PowerLook Density Assessment V4.0

iCAD, Inc.

PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesis synthesized2D images from tomosynthesis exams. PowerLook Density...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2021-07-12
FDA-cleared K203822

ProFound AI Software V3.0

iCAD Inc.

Concurrent or secondary CAD assistance to interpreting physicians for detection, localization, and characterization of soft-tissue densities (masses, architectural distortions,...

Modality
Mammography/DBT
Anatomy
Breast, including soft-tissue densities and calcifications in 3D DBT slices.
Decision
2021-03-12
FDA-cleared K191994

ProFound AI Software V2.1

iCAD Inc.

ProFound AI V2.1 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2019-10-04
FDA-cleared K182373

PowerLook Tomo Detection V2 Software

iCAD Inc.

PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2018-12-06
FDA-approved P160009

PowerLook® Tomo Detection Software

iCAD Inc

Concurrent computer-aided detection for radiologists interpreting compatible GE Senoclaire breast tomosynthesis examinations, with detected soft-tissue densities blended into the...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2017-03-24
FDA-approved P010034

SECOND LOOK ™

ICAD, INC.

The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has...

Modality
Mammography/DBT
Anatomy
Breast / standard mammographic views
Decision
2002-01-31