Rayvolve AZchest— 510(k) K261378

Substantially Equivalent

AZmed

FDA 510(k) clearance K261378 for Rayvolve AZchest, Substantially Equivalent on 2026-08-28. Applicant: AZmed. Device class: 2.

Clearance details

Applicant: AZmed
Product code: Code QBS
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2026-04-27
Decision date: 2026-08-28
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.