mdprostate— 510(k) K252571

Name: FDA 510(k) clearance K252571
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Substantially Equivalent

Mediaire GmbH

FDA 510(k) clearance K252571 for mdprostate, Substantially Equivalent on 2026-08-07. Applicant: Mediaire GmbH. Device class: 2.

Summary

Mediaire's mdprostate is filed under product code QIH, automated radiological image processing software. The record has no description beyond the name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Mediaire filed from Berlin, Germany. Review took 358 calendar days (August 14, 2025 to August 7, 2026) and ended in a substantially equivalent decision.

Clearance details

Applicant: Mediaire GmbH
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-08-14
Decision date: 2026-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.