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Medihub Prostate

by JLK, Inc.

510(k) K233196

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233196 Date21 Jun 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medihub Prostate is an AI-enabled diagnostic device designed for the analysis of prostate imaging data. It assists in the evaluation of prostate conditions, including potential cancer detection, by leveraging artificial intelligence to interpret medical images.

This device is supplied as a software-based solution and operates within a radiology setting. It is intended for single-use applications in MRI-compatible environments, adhering to FDA clearance under submission K233196. No specific sterility or reusable specifications are noted in the regulatory data.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical setting is the Medihub Prostate designed to operate in and how does it integrate with existing workflows?

    The Medihub Prostate is designed for use within radiology departments, specifically in MRI-compatible environments. As a software-based solution, it analyzes prostate imaging data to assist in evaluating conditions like potential prostate cancer. It integrates into existing workflows by processing MRI scans directly, providing AI-driven insights to support diagnostic evaluations without requiring additional hardware.

  • Is the Medihub Prostate intended for repeated use across multiple patients, or is it single-use per patient?

    The Medihub Prostate is explicitly described as a single-use application in its regulatory data. This means each instance of use is intended for one patient’s imaging data analysis, ensuring no cross-contamination or reuse concerns in clinical settings.

  • What type of regulatory clearance does the Medihub Prostate hold, and how does this affect its use in clinical practice?

    The Medihub Prostate holds FDA clearance under a 510(k) submission (K233196), classified as *Substantially Equivalent* to a predicate device. This clearance indicates it meets FDA standards for safety and effectiveness in its intended use—assisting radiologists in analyzing prostate MRI scans for diagnostic purposes. Clinicians may rely on this clearance to confirm its regulatory compliance for clinical deployment.

  • Does the Medihub Prostate require any special handling or storage conditions, such as temperature or environmental constraints?

    The regulatory data does not specify any special storage conditions for the Medihub Prostate, as it is a software-based solution. However, since it operates in MRI-compatible environments, it must be used in settings where electromagnetic interference is controlled. Standard IT infrastructure requirements (e.g., compatible hardware, network connectivity) should be ensured for optimal performance.