# K143440: Natus Quantum

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated
- Decided: Apr 20, 2015 after 139 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040360 (2004). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040360: EMU128S, Model EX-NW-128S, Excel Tech., Ltd. (2004) Summary page 4.
- K100683: Neurolink IP Model: PK1117, Natus Medical Incorporated (2010) Summary page 4.

## Most influential descendants
- K180290: Natus Brain Monitor Amplifier (2018), 1 descendant of its own
- K180181: Natus Quantum (2018), 1 descendant of its own
- K193159: NeuroAmp II, NeuroAmp II.5s (2020), 0 descendants of its own
- K181466: Cadwell Zenith System (2018), 0 descendants of its own

## Recalls of this device
- Nov 11, 2015 · Class II · Z-0581-2016: During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.

## Indications for use
The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery. The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

Source page: https://510kreport.com/device/K143440
Methodology: https://510kreport.com/methodology