# K242683: QP-Prostate® CAD

- Pathway: 510(k) (Traditional)
- Applicant: Quibim S.L.
- Decided: Mar 18, 2025 after 193 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212783: ProstatID, Scanmed, LLC (2022) Summary page 5.

## Indications for use
QP-Prostate® CAD is a Computed Aided Detection and Diagnosis (CADe/CADx) image processing software that automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI. The software is intended to be used as a concurrent read by physicians with proper training in a clinical setting as an aid for interpreting prostate MRI studies. The results can be displayed in a variety of DICOM outputs, including identified suspected lesions marked as an overlay onto source MR images. The output can be displayed on third-party DICOM workstations and Picture Archive and Communication Systems (PACS). Patient management decisions should not be based solely on the results of QP-Prostate® CAD. Intended patient population: Patients above 40 years with prostate MR imaging. Intended users: QP-Prostate® CAD is intended to be used by physicians with proper training, including radiologists, urologists and any physician qualified to read and interpret prostate MRI consistent with ACR recommendations in the context of PI-RADS.

Source page: https://510kreport.com/device/K242683
Methodology: https://510kreport.com/methodology