FDA.reportPublic FDA data

ProFound Detection

Primary DI
00850008977541
Brand
ProFound Detection
Company
Icad, Inc.
Model
4.0
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K240417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240417000ProFound Detection (V4.0)Icad, Inc.2024-11-08QDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008977541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008977541008500089775418500089775410850008977541

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

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
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
00850008977510PowerLook Cloud 1.0 DSC038-012023-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800076000230Lunit INSIGHT DBTLunit Inc.QDQ2026-04-17
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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
00858012005939PowerLook Tomo Detection (ProFound AI)Icad, Inc.QDQ2018-12-27