Rayvolve LN— 510(k) K243831

Substantially Equivalent

AZmed

FDA 510(k) clearance K243831 for Rayvolve LN, Substantially Equivalent on 2025-03-26. Applicant: AZmed. Device class: 2.

Clearance details

Applicant: AZmed
Product code: Code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2024-12-13
Decision date: 2025-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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