PowerLook Tomo Detection and SecondLook Digital License D70133

GUDID 00858012005663

The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital 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.

Icad, Inc.

Basic diagnostic x-ray system application software
Primary Device ID00858012005663
NIH Device Record Keye46a1510-4458-4e34-94d7-6e9d71a81db1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerLook Tomo Detection and SecondLook Digital License
Version Model NumberV1.1
Catalog NumberD70133
Company DUNS108870254
Company NameIcad, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-280-2239
Emailcustomersupport@icadmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYNAnalyzer,Medical Image

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-03

Devices Manufactured by Icad, Inc.

00850008977053 - TESTING2024-06-18
00850008977251 - PowerLook Density Assessment V4.02024-06-18
00850008977268 - ProFound AI 3.12024-06-18
00850008977275 - ProFound AI 3.12024-06-18
00850008977282 - TESTING2024-06-18
00850008977299 - PowerLook PRO+ 4GPU Tower Platform, OUS2024-06-18
00850008977305 - PowerLook 10.1.12024-06-18
00850008977312 - PowerLook MammoAI Container - Sectra2024-06-18

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