QP-Prostate CAD
by Quibim S.L. EUDAMED510(k)
Active
510(k) K242683
Overview
Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer, the QP-Prostate CAD is an AI-powered tool designed to identify and stratify intermediate and high-grade prostate cancer lesions. It provides automated segmentation of the prostate gland, enhancing radiologist workflows by improving detection accuracy and efficiency in MRI-based evaluations.
Supplied as software for use on radiology workstations, QP-Prostate CAD operates as a single-use digital solution within MRI-compatible environments. Authorised under FDA 510(k) clearance and MDR compliance, it is intended for integration with multiparametric MRI systems. The device requires no physical sterilisation but adheres to standard IT security and data protection protocols for medical imaging software. Registration numbers include 3023522713 through 3042248552 under product code QDQ.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK242683 | Date18 Mar 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- QDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2090
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quibim S.L.
Questions
How does the QP-Prostate® CAD software assist radiologists in evaluating prostate MRI scans, and what types of lesions does it focus on?
The QP-Prostate® CAD is an AI-powered tool designed to automate the segmentation of the prostate gland in MRI scans, helping radiologists improve detection accuracy and efficiency. It specifically targets intermediate and high-grade prostate cancer lesions, providing enhanced visualization and stratification to support more confident diagnostic workflows.
Is the QP-Prostate® CAD software intended for use with specific MRI systems, and what kind of environment does it require?
The QP-Prostate® CAD is authorized for integration with multiparametric MRI systems, meaning it is compatible with standard MRI setups used in radiology. Since it operates digitally on radiology workstations, it requires an MRI-compatible environment but does not need physical sterilization—only adherence to IT security and data protection protocols for medical imaging software.
How is the QP-Prostate® CAD supplied, and is it reusable or single-use?
The QP-Prostate® CAD is supplied as a software solution for radiology workstations, meaning it is a digital tool rather than a physical device. As a single-use digital solution, each analysis session is independent, and no physical reuse or sterilization is required—only proper IT security and data management protocols must be followed.
What regulatory pathways does the QP-Prostate® CAD follow, and which advisory committee was involved in its review?
The QP-Prostate® CAD has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). Its review was conducted by the FDA’s Radiology (RA) Advisory Committee, with a decision classified as Substantially Equivalent (SESE) under the traditional clearance pathway.
Are there multiple versions or registration numbers associated with the QP-Prostate® CAD, and what does this mean for compatibility?
Yes, the QP-Prostate® CAD has multiple registration numbers (e.g., 3023522713 through 3042248552) under product code QDQ, indicating different software versions or configurations. These variations are likely tailored for different MRI systems or workflows but remain compatible within the broader framework of multiparametric MRI environments, ensuring flexibility for radiology departments.