Prostate Core— 510(k) K253794

Name: FDA 510(k) clearance K253794
Creator: U.S. Food and Drug Administration
Published: 2026-08-10

Substantially Equivalent

Lucida Medical, Ltd.

FDA 510(k) clearance K253794 for Prostate Core, Substantially Equivalent on 2026-08-10. Applicant: Lucida Medical, Ltd.. Device class: 2.

Summary

Lucida Medical's Prostate Core 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, and it came in as a Traditional 510(k).

Lucida filed from Cambridge, United Kingdom. FDA found it substantially equivalent 255 calendar days after receipt (November 28, 2025 to August 10, 2026).

Clearance details

Applicant: Lucida Medical, Ltd.
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-28
Decision date: 2026-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

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