SwiftMR— 510(k) K261349
Substantially EquivalentAirs Medical, Inc.
FDA 510(k) clearance K261349 for SwiftMR, Substantially Equivalent on 2026-07-24. Applicant: Airs Medical, Inc.. Device class: 2.
Summary
SwiftMR from Airs Medical is filed under QIH, automated radiological image processing software. The name points to MR, but the record doesn't describe the processing or outputs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Airs Medical filed from Seoul, South Korea. The decision came 91 calendar days after FDA received it (April 24 to July 24, 2026).
Clearance details
- Applicant
- Airs Medical, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code QIH
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