encevis (2.1)
by Ait Austrian Institute of Technology GmbH Austria 510(k)
510(k) K240993 Product code OMB
Overview
The encevis (2.1) is an Automatic Event Detection Software For Full-Montage Electroencephalograph, as defined in the device specifications. It is classified as a Class II medical device under regulation number 882.1400 and is intended for use in neurology.
The device received FDA 510(k) clearance (K240993) on September 27, 2024, and is substantially equivalent to a predicate device. It is manufactured by AIT Austrian Institute of Technology GmbH in Vienna, Austria, and is supplied as a software product for use with electroencephalograph systems in clinical neurology settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240993 | Date27 Sep 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OMB
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ait Austrian Institute of Technology GmbH
See all devices from Ait Austrian Institute of Technology GmbH →
Questions
What is the encevis (2.1) used for?
The encevis (2.1) is intended for automatic event detection in full-montage electroencephalograph recordings, supporting clinical neurology workflows by identifying relevant EEG events as defined in its device specifications.
How is the encevis (2.1) supplied and deployed?
The encevis (2.1) is supplied as a software product designed for integration with electroencephalograph systems in clinical neurology settings, requiring compatible hardware and software environments to function as described in its labeling.
Is the encevis (2.1) a single-use or reusable software product?
As a software medical device, the encevis (2.1) is not subject to physical wear or consumption; its reuse depends on the terms of the software license and the compatibility of the host EEG system, with no inherent limitation on reinstallation or continued use under valid authorization.
What regulatory pathway was used for the encevis (2.1)?
The encevis (2.1) received FDA 510(k) clearance under submission K240993 on September 27, 2024, demonstrating substantial equivalence to a legally marketed predicate device under regulation 882.1400 for neurology-related EEG event detection software.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K240993