SwiftMR— 510(k) K253775

Substantially Equivalent

Airs Medical, Inc.

FDA 510(k) clearance K253775 for SwiftMR, Substantially Equivalent on 2026-03-26. Applicant: Airs Medical, Inc..

Clearance details

Applicant: Airs Medical, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-11-26
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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