ChestView US— 510(k) K241620

Substantially Equivalent

Gleamer Sas

FDA 510(k) clearance K241620 for ChestView US, Substantially Equivalent on 2025-02-27. Applicant: Gleamer Sas.

Clearance details

Applicant: Gleamer Sas
Product code: Code MYN
Advisory panel: Radiology
Date received: 2024-06-05
Decision date: 2025-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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