PowerLook Tomo Detection (ProFound AI)

GUDID 00858012005939

Icad, Inc.

Basic diagnostic x-ray system application software
Primary Device ID00858012005939
NIH Device Record Key7b66ec62-b820-4371-b8cd-1844e52eddb8
Commercial Distribution Discontinuation2019-07-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePowerLook Tomo Detection (ProFound AI)
Version Model NumberV2
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(866) 280-2239
EmailSupport@icadmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-12
Device Publish Date2018-12-27

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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