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FDA 510(k)

BrainInsight

K-Number: K202414 · 2021-01-07

ApplicantHyperfine Research, Inc.
Decision Date2021-01-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BrainInsight is a medical device manufactured by Hyperfine Research, Inc.. It received FDA 510(k) clearance on 2021-01-07 under approval number K202414. The device is classified under product code LLZ. 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 2021-01-07. It is manufactured by Hyperfine Research, Inc.. The 510(k) number is K202414.

When was BrainInsight approved by the FDA?

BrainInsight received FDA 510(k) clearance on 2021-01-07, under approval number K202414.

What company makes BrainInsight?

BrainInsight is manufactured by Hyperfine Research, Inc..

What is the FDA product code for BrainInsight?

The FDA product code for BrainInsight is LLZ.

Other Devices by Hyperfine Research, Inc.

K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K192002Lucy Point-of-Care Magnetic Resonance Imaging Device

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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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