# K252571: mdprostate

- Pathway: 510(k) (Traditional)
- Applicant: Mediaire GmbH
- Decided: Aug 7, 2026 after 358 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: 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
The product is intended for automatic segmentation, visualization, and volumetric quantification of the prostate on 3D MRI data (in DICOM format). The software automates the currently manual process of identifying, labeling and volumetric calculation of segmented prostate structures on 3D MRI images. The calculated volumetric data, in addition to the image data at hand, can assist trained medical professionals in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using mdprostate. The application of the software refers to patients with presumed changes in the prostate tissue and is intended to be used for men of age between 35 and 99 years.

Source page: https://510kreport.com/device/K252571
Methodology: https://510kreport.com/methodology