FDA.reportPublic FDA data

MammoScreen

Primary DI
B885MAML2US0
Brand
MammoScreen
Company
THERAPIXEL
Model
MAL2US
Device description
Radiological computer assisted detection and diagnosis software
Published
2022-01-20
Public version status
New
Distribution status
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
K211541000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211541000MammoScreen 2.0Therapixel2021-11-26QDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B885MAML2US0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+33625467635support@therapixel.com

Regulatory Flags#

DUNS number
265235524
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B885MAML0MammoScreenMAMLMAML2020-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437021468243QP-Prostate® CADQUIBIM SOCIEDAD LIMITADA.QDQ2026-06-05
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
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