# K120260: ICTA

- Pathway: 510(k) (Traditional)
- Applicant: Excel-Tech Ltd. (Xltek)
- Decided: Jun 29, 2012 after 154 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: 1 generation back to K090019 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090019: Natus Neuroworks, Model 104196, Natus Medical, Inc. (2010) Summary page 1.

## Indications for use
The ICTA software is intended as a review tool to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings (surface or intracranial) that may correspond to electrographic seizures, in order to assist qualified clinical practitioners, who will exercise professional judgment in using the information, in the assessment of EEG traces. Surface recordings must be obtained with full montage according to the standard 10/20 system. Intracranial recordings must be obtained with depth electrodes (strips and/or grids). This device does not provide any diagnostic conclusion about the patient's condition to the user.

Source page: https://510kreport.com/device/K120260
Methodology: https://510kreport.com/methodology