Powerlook PRO with SLD, GE, US DSC017-04-US

GUDID 00858012005854

The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Icad, Inc.

Basic diagnostic x-ray system application software
Primary Device ID00858012005854
NIH Device Record Key843aeae8-f924-49eb-858c-589f80dab29e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerlook PRO with SLD, GE, US
Version Model NumberV7.2
Catalog NumberDSC017-04-US
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

Phone866-280-2239
Emailsupport@icadmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005854 [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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