Galen Second Read— 510(k) K241232

Substantially Equivalent

Ibex Medical Analytics , Ltd.

FDA 510(k) clearance K241232 for Galen Second Read, Substantially Equivalent on 2025-01-24. Applicant: Ibex Medical Analytics , Ltd..

Clearance details

Applicant: Ibex Medical Analytics , Ltd.
Product code: Code QPN
Advisory panel: Pathology
Date received: 2024-05-02
Decision date: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

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