FDA 510(k)

SwiftMR

K-Number: K261349 · 2026-07-24

Decision Date2026-07-24

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SwiftMR is the device name listed in this FDA 510(k) record. The listed applicant is Airs Medical, Inc.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K261349. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SwiftMR?

SwiftMR is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Airs Medical, Inc.. The 510(k) number is K261349.

When did SwiftMR receive FDA 510(k) clearance?

SwiftMR received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261349.

Who is the listed applicant for SwiftMR?

The FDA 510(k) record lists Airs Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SwiftMR?

The FDA product code for SwiftMR is QIH.

Other records listing Airs Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253775SwiftMR K251483SwiftSight-Brain K230854SwiftMR K220416SwiftMR K210999SwiftMR

Related Devices (Code: QIH)

K260192DIANAROPCA ApS K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.K261535Hi-D Imaging 4TAVRHi-D Imaging AG K260206SkeletonPlannerUPlanner B.V. - Presurgeo K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.K253969ADAS 3DAdas3D Medical S.L.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.