SwiftMR— 510(k) K253775

Name: FDA 510(k) clearance K253775
Creator: U.S. Food and Drug Administration
Published: 2026-03-26

Substantially Equivalent

Airs Medical, Inc.

FDA 510(k) clearance K253775 for SwiftMR, Substantially Equivalent on 2026-03-26. Applicant: Airs Medical, Inc.. Device class: 2.

Summary

Airs Medical's SwiftMR is filed under QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Airs Medical filed from Seoul, South Korea. Review took 120 calendar days (November 26, 2025 to March 26, 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: 2025-11-26
Decision date: 2026-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Airs Medical, Inc.

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K261612 — SwiftSight-BodyComposition2026-10-01
K261349 — SwiftMR2026-07-24
K251483 — SwiftSight-Brain2025-09-23
K230854 — SwiftMR2023-10-27
K220416 — SwiftMR2022-05-25

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