# K252608: AI-Rad Companion Prostate MR

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Sep 9, 2025 after 22 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K971684 (1997). 192 ancestors in all.
No later device cites it as a predicate yet.
5 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193283: AI-Rad Companion Prostate MR, Siemens Medical Solutions USA, Inc. (2020) Summary page 6.

## Indications for use
AI-Rad Companion Prostate MR is indicated for the processing and annotation of DICOM MR prostate images acquired in adult male populations that demonstrate indications of oncological abnormalities in the prostate. The AI-Rad Companion Prostate MR software aims to support the radiologist and provides the following functionality: • Viewing, analyzing, evaluating prostate MR images including DCE, ADC, T2 and DWI • Hosting application for and provides interface to external Prostate MR AI plug-in device • Accept/reject/edit the results generated by the plug-in software Prostate MR AI

Source page: https://510kreport.com/device/K252608
Methodology: https://510kreport.com/methodology