FDA.reportPublic FDA data

PowerLook AMP with Density Assessment GE US

Primary DI
00850008977183
Brand
PowerLook AMP with Density Assessment GE US
Company
Icad, Inc.
Model
DSC012-02
Published
2021-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850008977183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008977183008500089771838500089771830850008977183

GMDN Terms#

Term, Definition table
TermDefinition
Basic x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
108870254
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008977176ProFound AI V3.03.02021-05-17
00850008977190PowerLook AMP with Density Assessment GE OUSDSC012-032021-05-17
00858012005090PowerLook AMP SLD GE OUSDSC010-01-EU2021-05-17
00858012005106PowerLook AMP SLD GE OUS DirectDSC010-12-EU2021-05-17
00858012005113PowerLook AMP SLD Siemens OUSDSC010-03-EU2021-05-17
00858012005120PowerLook AMP SLD Fuji OUSDSC010-04-EU2021-05-17
00858012005137PowerLook AMP SLD Hologic OUSDSC010-05-EU2021-05-17
00858012005144PowerLook AMP SLD GiottoDSC010-062021-05-17
00858012005151PowerLook AMP SLD Philips OUSDSC010-07-EU2021-05-17
00858012005168PowerLook AMP SLD PlanmedDSC010-082021-05-17
00858012005175PowerLook AMP SLD Agfa CRDSC010-092021-05-17
00858012005236PowerLook PRO Tomo Detection and SLD, GEV1.1DSC014-01-EU2021-05-17
00858012005250PowerLook PRO Tomo Detection and SLD, GEV1.1DSC014-02-EU2021-05-17
00858012005809Powerlook PRO Hardware Upgrade, SLDV7.2DSC017-02-ROW2021-05-17
00858012005823Powerlook PRO Hardware Upgrade, SLDV7.2DSC017-03-ROW2021-05-17
00858012005830PowerLook AMP PRO, SLD, GE, ROWV7.2DSC017-01-ROW2021-05-17
00858012005847PowerLook AMP PRO, SLD, GE, ROWV7.2DSC017-04-ROW2021-05-17
00858012005960ProFound AI2.12019-07-11
00858012005007SecondLook Digital (SLD)V7.2DS02062014-09-22
00858012005014PowerLook AMP SLD GE USV7.2DSC010-01-US2014-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
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00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01
00817886020448JointsMEDSTRAT, INC.LLZ2022-06-17