QP-Prostate® CAD

Primary DI
08437021468236
Brand
QP-Prostate® CAD
Company
QUIBIM SOCIEDAD LIMITADA.
Model
1.2
Device description
QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
Published
2026-03-06
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
K242683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242683000QP-Prostate® CADQuibim S.L.2025-03-18QDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437021468236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437021468236084370214682368437021468236

GMDN Terms#

Term, Definition table
TermDefinition
MRI image interpretive softwareAn interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data (e.g., prostate MRI) to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be intended for three-dimensional (3-D) model creation slice-based images (segmentation). 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
+34 961243225support@quibim.com

Regulatory Flags#

DUNS number
464843370
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437021468045QP-Brain®1.02026-05-06
08437021468175QP-Prostate1.62025-07-04
08437021468168QP-Prostate® CAD1.12025-05-02
08437021468120QP-Prostate® CAD1.02025-03-28
08437021468144QP-Prostate1.52024-11-04
08437021468052QP-Prostate1.42024-08-01

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
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