# K171384: Micromed BRAIN QUICK system

- Pathway: 510(k) (Traditional)
- Applicant: Micromed S.P.A.
- Decided: Feb 1, 2018 after 266 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: 8 generations back to K884937 (1989). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122196: Cervello Bio-Potential Signal Acquistion System Product Family, Blackrock Neuromed, LLC (2013) Summary page 4.
- K071782: Micromed Brain Spy Plus, Embia Titanium Devices, Micromed S.P.A. (2008) Summary page 4.

## Recalls of this device
- May 4, 2026 · Class II · Z-2353-2026: Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channe

## Indications for use
The Micromed BRAIN QUICK system is intended to acquire and store physiological signals for EEG and/or polysomnography (PSG) and to transfer data to separate PSG analysis software. The system includes: -hardware recorders intended to acquire and temporarily store physiological signals for EEG and/or PSG and to transfer the data to separate polysomnographic analysis software, and -software which is used for the signal acquisition, display, storage, process and measure of biologic signals. The hardware recorders (amplifiers) are BRAIN SPY PLUS, MORPHEUS, SD LTM 32 EXPRESS and SD LTM 64 EXPRESS. They are intended to acquire the same kind of signals by using the SystemPlus EVOLUTION software. The recorder models differ based on the number of available EEG channels (16 in the BRAIN SPY PLUS, 24 in the MORPHEUS, 32 in SD LTM 32 EXPRESS and 64 in SD LTM 64 EXPRESS). A system with up to 256 channel can be obtained by cascading 4 SD LTM 64 EXPRESS amplifiers. The device is intended to be used by physicians, technicians, and other medical professions that are trained in EEG and/or PSG.

Source page: https://510kreport.com/device/K171384
Methodology: https://510kreport.com/methodology