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FDA 510(k)

SwiftSight-Brain

K-Number: K251483 · 2025-09-23

ApplicantAirs Medical, Inc.
Decision Date2025-09-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SwiftSight-Brain is a medical device manufactured by Airs Medical, Inc.. It received FDA 510(k) clearance on 2025-09-23 under approval 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. It is manufactured by Airs Medical, Inc.. The 510(k) number is K251483.

When was SwiftSight-Brain approved by the FDA?

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

What company makes SwiftSight-Brain?

SwiftSight-Brain is manufactured by Airs Medical, Inc..

What is the FDA product code for SwiftSight-Brain?

The FDA product code for SwiftSight-Brain is QIH.

Other Devices by Airs Medical, Inc.

K210999SwiftMR K220416SwiftMR K230854SwiftMR K253775SwiftMR

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Official Source

View on FDA Database →

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

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