FDA 510(k)

SwiftSight-Brain

K-Number: K251483 · 2025-09-23

Decision Date2025-09-23

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SwiftSight-Brain 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 2025-09-23 under 510(k) number K251483. 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 SwiftSight-Brain?

SwiftSight-Brain is a medical device that received FDA 510(k) clearance on 2025-09-23. The listed applicant is Airs Medical, Inc.. The 510(k) number is K251483.

When did SwiftSight-Brain receive FDA 510(k) clearance?

SwiftSight-Brain received FDA 510(k) clearance on 2025-09-23, under 510(k) number K251483.

Who is the listed applicant for SwiftSight-Brain?

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 SwiftSight-Brain?

The FDA product code for SwiftSight-Brain 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.

K261349SwiftMR K253775SwiftMR K230854SwiftMR K220416SwiftMR K210999SwiftMR

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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.