autoSCORE is an AI-enabled medical device from Holberg EEG AS that the U.S. FDA cleared through 510(k) K231068 on January 7, 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 number | K231068 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Holberg EEG AS |
| Lead review panel | Neurology |
| Primary product code | OMB — Automatic Event Detection Software For Full-Montage Electroencephalograph |
| Applicant (openFDA) | Holberg Eeg AS |
| Applicant location | Bergen, NO |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.1400 |
| Decision code | SESE |
| Submission type | Traditional |
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. autoSCORE went through this pathway (K231068).
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 #4 of 8 under that code. Holberg EEG AS has 2 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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