FDA.reportPublic FDA data

PowerLook PRO Tomo Detection and SLD, GE

Primary DI
00858012005250
Brand
PowerLook PRO Tomo Detection and SLD, GE
Company
Icad, Inc.
Model
V1.1
Catalog number
DSC014-02-EU
Device description
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYNAnalyzer,Medical Image

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160009000PowerLook® Tomo Detection SoftwareIcad, Inc.2017-03-24MYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858012005250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858012005250008580120052508580120052500858012005250

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.

Contacts#

Phone, Email table
PhoneEmail
1-866-280-2239customersupport@icadmed.com

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
00850008977183PowerLook AMP with Density Assessment GE USDSC012-022021-05-17
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
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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07332747221855DTX Studio™ AssistNobel Biocare ABMYN2025-12-01
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07332747221183DTX Studio™ ClinicNobel Biocare ABMYN2025-04-24
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08908023670038DeepTek CXR AnalyzerDEEPTEK MEDICAL IMAGING PRIVATE LIMITEDMYN2025-04-24
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M722XC25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
M722XD25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
07332747219616DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
07332747219623DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
00860003567920Second OpinionPearl Inc.MYN2025-01-10
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00860005586318Overjet Caries AssistOverjet, Inc.MYN2024-11-12
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