PowerLook® Tomo Detection Software

FDA premarket approval P160009 · Analyzer, medical image

PMA numberP160009

Approval

Applicant
Icad, Inc.
Received
April 5, 2016
Decision date
March 24, 2017 (APRL)
Supplements
0
Product code
MYN – Analyzer, Medical Image

Official FDA PMA record

Approval order statement

Approval for the iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE Senoclaire breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.