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FDA 510(k)

BrainInsight

K-Number: K223268 · 2022-12-16

ApplicantHyperfine, Inc.
Decision Date2022-12-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BrainInsight is a medical device manufactured by Hyperfine, Inc.. It received FDA 510(k) clearance on 2022-12-16 under approval number K223268. 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 BrainInsight?

BrainInsight is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Hyperfine, Inc.. The 510(k) number is K223268.

When was BrainInsight approved by the FDA?

BrainInsight received FDA 510(k) clearance on 2022-12-16, under approval number K223268.

What company makes BrainInsight?

BrainInsight is manufactured by Hyperfine, Inc..

What is the FDA product code for BrainInsight?

The FDA product code for BrainInsight is QIH.

Other Devices by Hyperfine, Inc.

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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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