autoSCORE (V 2.0.0)
by Holberg Eeg AS Norway EUDAMED510(k)
510(k) K243743
Product code OMB
Overview
autoSCORE (Version 2.0.0) is an Automatic Event Detection Software for Full-Montage Electroencephalograph, designed to analyze and classify EEG data. It functions as a Class II medical device, leveraging algorithms to detect and score epileptiform events in continuous EEG recordings, aiding neurologists in diagnostic assessments.
This software is supplied as a digital tool for use in clinical settings, including hospitals and neurology practices, and operates on compatible EEG systems. It is intended for single-use per recording session, with no sterility requirements, and is compatible with MRI environments as it does not contain metallic components. Authorized under FDA 510(k) clearance and MDR compliance, it is regulated under the OMB product code and regulation number 882.1400 for neurology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK243743 | Date9 Apr 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
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 Holberg Eeg AS
Questions
What is the primary purpose of the autoSCORE (V 2.0.0) software in clinical settings?
autoSCORE (V 2.0.0) is designed as an Automatic Event Detection Software for Full-Montage Electroencephalograph (EEG). Its purpose is to analyze and classify epileptiform events in continuous EEG recordings, assisting neurologists in diagnosing epilepsy or related neurological conditions by automating the detection and scoring process.
How is the autoSCORE software supplied and is it reusable?
autoSCORE is supplied as a digital tool for use on compatible EEG systems in clinical environments like hospitals and neurology practices. It is intended for single-use per recording session, meaning it is not designed for repeated use on the same data set without reinitialization.
Does autoSCORE require sterility or contain metallic components that could interfere with MRI?
Since autoSCORE is a software-based solution, it does not require sterility (as it is not a physical device) and contains no metallic components. This makes it compatible with MRI environments, as there is no risk of interference from metal.
What regulatory pathways does autoSCORE follow, and which advisory committee oversees its classification?
autoSCORE (V 2.0.0) is regulated under FDA 510(k) clearance and MDR compliance, with a classification as a Class II medical device. Its submission was reviewed by the Neurology (NE) Advisory Committee, and it falls under the OMB product code and regulation number 882.1400 for neurology applications.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K243743
- EUDAMED