# K241770: Prostate MR AI (VA10A)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Mar 5, 2025 after 258 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: 2 generations back to DEN180005 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181704: Transpara, Screenpoint Medical B.V. (2018) Summary page 5.

## Indications for use
Prostate MR AI is a plug-in Radiological Computer Assisted Detection and Diagnosis Software device intended to be used • with a separate hosting application • as a concurrent reading aid to assist radiologists in the interpretation of a prostate MRI examination acquired according to the PI-RADS standard • in adult men (40 years and older) with suspected cancer in treatment naïve prostate glands The plug-in software analyzes non-contrast T2 weighted (T2W) and diffusion weighted image (DWI) series to segment the prostate gland and to provide an automatic detection and segmentation of regions suspicious for cancer. For each suspicious region detected, the algorithm moreover provides a lesion Score, by way of PI-RADS interpretation suggestion. Outputs of the device should be interpreted consistently with ACR recommendations using all available MR data (e.g., dynamic contrast enhanced images [if available]). Patient management decisions should not be made solely based on analysis by the Prostate MR AI algorithm.

Source page: https://510kreport.com/device/K241770
Methodology: https://510kreport.com/methodology