SwiftSight-BodyComposition— 510(k) K261612
Substantially EquivalentAirs Medical, Inc.
FDA 510(k) clearance K261612 for SwiftSight-BodyComposition, Substantially Equivalent on 2026-10-01. Applicant: Airs Medical, Inc.. Device class: 2.
Summary
SwiftSight-BodyComposition from Airs Medical is filed under LNH, nuclear magnetic resonance imaging systems. The name points to body composition analysis, but the record doesn't say whether it's software, hardware, or both.
Class II, 21 CFR 892.1000. The Radiology panel reviewed it as a Traditional 510(k).
Airs Medical filed from Seoul, South Korea. Review took 139 days (May 15 to October 1, 2026).
Clearance details
- Applicant
- Airs Medical, Inc.
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code LNH
view allMore clearances from Airs Medical, Inc.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.