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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DevicePowerLook® Tomo Detection Software
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantiCAD Inc
98 Spitbrook Road, Suite 100
Nashua, NH 03062
PMA NumberP160009
Date Received04/05/2016
Decision Date03/24/2017
Reclassified Date 02/21/2020
Product Code MYN 
Docket Number 17M-1950
Notice Date 03/29/2017
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness