Prostate Core— 510(k) K253794

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.

Clearance details

Applicant: Lucida Medical, Ltd.
Product code: 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.