# K231068: autoSCORE

- Pathway: 510(k) (Traditional)
- Applicant: Holberg Eeg AS
- Decided: Jan 7, 2024 after 268 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K132306 (2013). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171720: encevis, Ait Austrian Institute of Technology GmbH (2018) Summary page 5.
- K151929: Persyst 13 (P13) Eeg Review and Analysis Software, Persyst Development Corporation (2015) Summary page 5.

## Most influential descendants
- K243743: autoSCORE (V 2.0.0) (2025), 1 descendant of its own
- K260998: Ceribell Neurology Review Software (2026), 0 descendants of its own

## Indications for use
1. autoSCORE is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. 2. The spike detection component of autoSCORE is intended to mark previously acquired sections of the patient’s EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The spike detection component is intended to be used in patients at least three months old. The autoSCORE component has not been assessed for intracranial recordings. 3. autoSCORE is intended to assess the probability that previously acquired sections of EEG recordings contain abnormalities, and classifies these into pre-defined types of abnormalities, including epileptiform and non-epileptiform abnormalities. autoSCORE does not have a user interface. autoSCORE sends this information to the EEG reviewing software to indicate where markers indicating abnormality are to be placed in the EEG. autoSCORE also provides the probability that EEG recordings include abnormalities and the type of abnormalities. The user is required to review the EEG and exercise their clinical judgement to independently make a conclusion supporting or not supporting brain disease. 4. This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is not intended to detect or classify seizures.

Source page: https://510kreport.com/device/K231068
Methodology: https://510kreport.com/methodology