PMA P160009

Device

PowerLook® Tomo Detection Software

Applicant

Icad, Inc.

PMA number

P160009

Product code

MYN

Decision date

2017-03-24

Classification

Analyzer, Medical Image

Generic name

Analyzer, medical image

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.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160009B.pdf" target="_new">Summary of Safety and Effectiveness</a>