# K092039: Identevent, Version 1.0G

- Pathway: 510(k) (Traditional)
- Applicant: Optima Neuroscience, Inc.
- Decided: Oct 16, 2009 after 102 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: 3 generations back to K801604 (1980). 17 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011397: Persyst Reveal, Persyst Development Corp. (2001) Summary page 1.
- K041263: Neuroguide Analysis System, Applied Neuroscience, Inc. (2004) Summary page 1.

## Most influential descendants
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own
- K240593: VEEGix EEG System (2024), 0 descendants of its own

## Indications for use
IdentEventTM is a software-only product with an algorithm intended to analyze previously acquired, adult (>18 years) scalp EEG signals and mark events that may correspond to electrographic seizures for the purpose of reviewing prolonged EEG traces. The marked events are reviewed, possibly deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information. IdentEvent also includes the display of the quantitative EEG parameters Amplitude Variation and Maximum Frequency, which are intended to help the user analyze the EEG waveform after it has been collected. IdentEvent requires the use of EEGs recorded with at least a 16-channel scalp montage following the standard 10/20 electrode placement system. IdentEvent does not provide any diagnostic conclusion about the patient's condition to the user.

Source page: https://510kreport.com/device/K092039
Methodology: https://510kreport.com/methodology