FDA 510(k)

BrainInsight

K-Number: K202414 · 2021-01-07

Decision Date2021-01-07

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BrainInsight is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine Research, Inc.. It received FDA 510(k) clearance on 2021-01-07 under 510(k) 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. The listed applicant is Hyperfine Research, Inc.. The 510(k) number is K202414.

When did BrainInsight receive FDA 510(k) clearance?

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

Who is the listed applicant for BrainInsight?

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

What is the FDA product code for BrainInsight?

The FDA product code for BrainInsight is LLZ.

Other records listing Hyperfine Research, 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.

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

Related Devices (Code: LLZ)

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.