Rayvolve PTX-PE— 510(k) K243808

Substantially Equivalent

AZmed

FDA 510(k) clearance K243808 for Rayvolve PTX-PE, Substantially Equivalent on 2025-03-21. Applicant: AZmed.

Clearance details

Applicant: AZmed
Product code: Code QFM
Advisory panel: Radiology
Date received: 2024-12-11
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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