# K193283: AI-Rad Companion Prostate MR

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 30, 2020 after 246 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 15 generations back to K971684 (1997). 191 ancestors in all.
2 later devices descend from it; 2 cite it directly.
5 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180336: syngo.MR Applications, Siemens Medical Solutions USA, Inc. (2018) Summary page 5.

## Most influential descendants
- K252571: mdprostate (2026), 0 descendants of its own
- K252608: AI-Rad Companion Prostate MR (2025), 0 descendants of its own

## Indications for use
AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support. Al-Rad Companion Prostate MR provides the following functionalities: - Automatic segmentation and quantitative analysis of the prostate gland - Manual annotation of relevant findings - Presentation and export of results for further processing and reporting

Source page: https://510kreport.com/device/K193283
Methodology: https://510kreport.com/methodology