# K233196: Medihub Prostate

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Jun 21, 2024 after 267 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: 3 generations back to K121517 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202501: Quantib Prostate, Quantib B.V. (2020) Summary page 4.

## Indications for use
MEDIHUB PROSTATE is an image processing software package that performs outlining, processing, viewing, and editing of prostate MR images. The software can support study review and analysis of prostate MR data with computed modules. The analysis result can be presented in various formats, including images overlaid onto source MR images and a structured report. MEDIHUB PROSTATE semi-automatically outlines the prostate based on MR images by contour, and it requires the user to edit with image manipulating tools and confirm the final result. The package provides additional functionalities including registered multiparametric-MRI viewing and combining MR sequences into a single image to support visualization. Edited PI-RADS report and semi annotated prostate region can be viewed in each single image in the final report. MEDIHUB PROSTATE is intended to be used by trained radiologists and urologists. Patient management decisions should not be made solely based on the analysis performed by MEDIHUB PROSTATE. Limitations: * MEDIHUB PROSTATE has been validated for use with Siemens 3T Vida and Skyra MRI machines. * MEDIHUB PROSTATE is also designed for use with the Siemens 3T T2 MRI series, supporting slice thicknesses ranging from 3.5 mm to 5 mm. * MEDIHUB PROSTATE has been tested on patients aged 55 years and above.

Source page: https://510kreport.com/device/K233196
Methodology: https://510kreport.com/methodology