# K023771: SYNAMPS2

- Pathway: 510(k) (Abbreviated)
- Applicant: Neuroscan
- Decided: Feb 6, 2003 after 86 days
- Product code: GWQ (Full-Montage Standard 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 K001324 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K001324: Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256 Channels), Neuro Scan Labs (2000)

## Most influential descendants
- K081151: Compumedics Neuvo (2008), 2 descendants of its own
- K093223: Compumedics Grael System, Models: Grael, Grael Ecg (2010), 1 descendant of its own
- K230073: Okti (2023), 0 descendants of its own
- K042364: Panbus Digital Eeg & Sleep Acquisition Devices (2004), 0 descendants of its own

## Indications for use
The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient’s brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualifiedtrained EEG technologists andor physicians. The data acquired must be interpreted by qualified physicians.

Source page: https://510kreport.com/device/K023771
Methodology: https://510kreport.com/methodology