510(k) · Radiology

BrainInsight

by Hyperfine Research, Inc

BrainInsight is an AI-enabled medical device from Hyperfine Research, Inc that the U.S. FDA cleared through 510(k) K202414 on January 7, 2021. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK202414
Pathway510(k)
Date of final decision
Company (FDA list)Hyperfine Research, Inc
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Hyperfine Research, Inc.
Applicant locationGuildford, CT, US
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. BrainInsight went through this pathway (K202414).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #89 of 161 under that code. Hyperfine Research, Inc has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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