FDA.reportPublic FDA data

PowerLook Tomo Detection (ProFound AI)

Primary DI
00858012005939
Brand
PowerLook Tomo Detection (ProFound AI)
Company
Icad, Inc.
Model
V2
Published
2018-12-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182373000PowerLook Tomo Detection V2 SoftwareIcad, Inc.2018-12-06QDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858012005939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858012005939008580120059398580120059390858012005939

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

Contacts#

Phone, Email table
PhoneEmail
(866) 280-2239Support@icadmed.com

Regulatory Flags#

DUNS number
108870254
Device count
1

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800076000230Lunit INSIGHT DBTLunit Inc.QDQ2026-04-17
00850008977541ProFound DetectionIcad, Inc.QDQ2026-03-23
08437021468236QP-Prostate® CADQUIBIM SOCIEDAD LIMITADA.QDQ2026-03-06
08437021468168QP-Prostate® CADQUIBIM SOCIEDAD LIMITADA.QDQ2025-05-02
08437021468120QP-Prostate® CADQUIBIM SOCIEDAD LIMITADA.QDQ2025-03-28
08720387058051TransparaScreenpoint Medical B.V.QDQ2024-11-28
00860006305727See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QDQ2024-11-22
08800076000162Lunit INSIGHT DBTLunit Inc.QDQ2024-04-09
08800076000148Lunit INSIGHT DBTLunit Inc.QDQ2023-12-01
00860009082601Bot Image, Inc.Bot Image, Inc.QDQ2023-03-17
00860009082625Bot Image, Inc.Bot Image, Inc.QDQ2023-03-17
08720387058013TransparaScreenpoint Medical B.V.QDQ2023-03-03
00860009082618Bot Image, Inc.Bot Image, Inc.QDQ2023-01-11
00860005144013Saige-DxDeephealth, Inc.QDQ2022-05-26
08800076000056Lunit INSIGHT MMGLunit Inc.QDQ2022-04-28
B885MAML2US0MammoScreenTHERAPIXELQDQ2022-01-20
08719326450131TransparaScreenpoint Medical B.V.QDQ2021-07-23
00850008977176ProFound AI V3.0Icad, Inc.QDQ2021-05-17
B885MAML0MammoScreenTHERAPIXELQDQ2020-06-23
08719326450117TransparaScreenpoint Medical B.V.QDQ2020-03-16
08719326450124TransparaScreenpoint Medical B.V.QDQ2019-12-12
00858012005960ProFound AIIcad, Inc.QDQ2019-07-11
08719326450100TransparaScreenpoint Medical B.V.QDQ2019-02-04