510(k) · Neurology

encevis (2.1)

by AIT Austrian Institute of Technology GmbH

encevis (2.1) is an AI-enabled medical device from AIT Austrian Institute of Technology GmbH that the U.S. FDA cleared through 510(k) K240993 on September 27, 2024. Its lead review panel is Neurology and its primary product code is OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph).

See also FDA-cleared AI neurology devices in 2024, all FDA AI clearances in 2024, top neurology AI devices.

Key facts

Submission numberK240993
Pathway510(k)
Date of final decision
Company (FDA list)AIT Austrian Institute of Technology GmbH
Lead review panelNeurology
Primary product codeOMB — Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant (openFDA)Ait Austrian Institute of Technology GmbH
Applicant locationVienna, AT
Device classClass 2
Regulation number21 CFR 882.1400
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. encevis (2.1) went through this pathway (K240993).

openFDA lists it as a Class 2 device under 21 CFR 882.1400. Class II devices are moderate risk and are subject to general and special controls.

Product code OMB covers 8 devices on the FDA AI list. By decision date, this device is #5 of 8 under that code. AIT Austrian Institute of Technology GmbH has 1 AI-enabled device 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.

Similar devices (product code OMB)