PowerLook PRO+ 4GPU Tower Platform, OUS

GUDID 00850008977299

Icad, Inc.

Radiology DICOM image processing application software
Primary Device ID00850008977299
NIH Device Record Keyf3c9be04-5467-4ee0-80c3-322865b07043
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerLook PRO+ 4GPU Tower Platform, OUS
Version Model NumberDSC018-08
Company DUNS108870254
Company NameIcad, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008977299 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-18
Device Publish Date2024-06-10

On-Brand Devices [PowerLook PRO+ 4GPU Tower Platform, OUS]

00850008977428DSC032-01, DSC032-02, DSC032-03
00850008977299DSC018-08

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