FDA.reportPublic FDA data

PowerLook AMP with Density Assessment GE OUS

Primary DI
00850008977190
Brand
PowerLook AMP with Density Assessment GE OUS
Company
Icad, Inc.
Model
DSC012-03
Published
2021-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180125000PowerLook Density Assessment SoftwareIcad, Inc.2018-04-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008977190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008977190008500089771908500089771900850008977190

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108870254
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008977541ProFound Detection4.02026-03-23
00850008977282TESTING2.02024-06-10
00850008977053TESTING1.02024-06-10
00850008977251PowerLook Density Assessment V4.04.02024-06-10
00850008977268ProFound AI 3.13.12024-06-10
00850008977275ProFound AI 3.13.12024-06-10
00850008977299PowerLook PRO+ 4GPU Tower Platform, OUSDSC018-082024-06-10
00850008977305PowerLook 10.1.1D4D02312024-06-10
00850008977312PowerLook MammoAI Container - SectraDSC026-012024-06-10
00850008977329PowerLook MammoAI Container - ArterysDSC028-012024-06-10
00850008977343PowerLook 11112024-06-10
00850008977350PowerLook MammoAI Container - GE1.02024-06-07
00850008977367PowerLook 11.111.12024-06-07
00850008977374PowerLook PRO+, OUSDSC030-01, DSC030-02, DSC030-032024-06-07
00850008977381PowerLook PRO+ 2GPU Tower Platform, USDSC029-01, DSC029-02, DSC029-032024-06-07
00850008977398PowerLook PRO+ Rack-Mount, OUSDSC034-01, DSC034-02, DSC034-032024-06-07
00850008977404PowerLook PRO+ Rack-Mount, USDSC033-01, DSC033-02, DSC033-032024-06-07
00850008977411PowerLook PRO+ 4GPU Tower Platform, USDSC031-01, DSC031-02, DSC031-032024-06-07
00850008977534PowerLook AI Mammo Container 1.0.0 BlackfordDSC036-012024-06-07
00850008977428PowerLook PRO+ 4GPU Tower Platform, OUSDSC032-01, DSC032-02, DSC032-032023-07-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
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06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
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04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
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