510(k) · Neurology

ENT EM

by Brainlab AG

ENT EM is an AI-enabled medical device from Brainlab AG that the U.S. FDA cleared through 510(k) K223734 on April 27, 2023. Its lead review panel is Neurology and its primary product code is PGW (Ear, Nose, And Throat Stereotaxic Instrument).

See also FDA-cleared AI neurology devices in 2023, all FDA AI clearances in 2023, top neurology AI devices.

Key facts

Submission numberK223734
Pathway510(k)
Date of final decision
Company (FDA list)Brainlab AG
Lead review panelNeurology
Primary product codePGW — Ear, Nose, And Throat Stereotaxic Instrument
Applicant (openFDA)Brainlab AG
Applicant locationMunich, DE
Device classClass 2
Regulation number21 CFR 882.4560
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. ENT EM went through this pathway (K223734).

openFDA lists it as a Class 2 device under 21 CFR 882.4560. Class II devices are moderate risk and are subject to general and special controls.

Product code PGW covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Brainlab AG has 9 AI-enabled devices on the list, and the Neurology panel accounts for 73 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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