# K123665: Lifelines Ieeg

- Pathway: 510(k) (Traditional)
- Applicant: Kvikna Ehf
- Decided: Mar 25, 2013 after 117 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- 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 K964280 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K964280: DG Nervus, Medelec, Ltd. (1997) Summary page 1.
- K021185: Nervus Monitor, Taugagreining HF (2002) Summary page 1.

## Indications for use
The Lifelines iEEG is a software system that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. * The Lifelines iEEG software allows display, archive, review and analysis of physiological signals. * Lifelines iEEG also includes the display of a quantitative EEG plot, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Source page: https://510kreport.com/device/K123665
Methodology: https://510kreport.com/methodology