# K243746: Delphi Amplifier

- Pathway: 510(k) (Traditional)
- Applicant: Quantalx Neroscience
- Decided: Mar 12, 2025 after 97 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K060374 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172312: eego amplifiers, Eemagine Medical Imaging Solutions GmbH (2018) Summary page 5.

## Indications for use
The Delphi Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician’s office, etc.). The device is not intended for use in life support systems.

Source page: https://510kreport.com/device/K243746
Methodology: https://510kreport.com/methodology