Galen Second Read— 510(k) K241232

Name: FDA 510(k) clearance K241232
Creator: U.S. Food and Drug Administration
Published: 2025-01-24

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.. Device class: 2.

Clearance details

Applicant: Ibex Medical Analytics , Ltd.
Product code: Code QPN
Device class: Class 2
Regulation: 21 CFR 864.3750
Advisory panel: Pathology
Date received: 2024-05-02
Decision date: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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