# K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Mar 16, 2012 after 28 days
- Product code: OMA (Amplitude-Integrated 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: 8 generations back to K875179 (1988). 71 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092573: Nihon Kohden QP-160AK Eeg Trend Program, Nihon Kohden America, Inc. (2010) Summary page 1.
- K041263: Neuroguide Analysis System, Applied Neuroscience, Inc. (2004) Summary page 1.
- K082886: Zoom-100DC, Brainscope Company, Inc. (2009) Summary page 1.

## Most influential descendants
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own
- K240593: VEEGix EEG System (2024), 0 descendants of its own
- K163644: Nihon Kohden QP-160AK EEG Trend Program (2017), 0 descendants of its own
- K130238: Nihon Kohden AE-918P Neuro Unit (2015), 0 descendants of its own

## Indications for use
The QP- I60AK Trend program is a software-only device intended to be installed on the EEG-1I200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1 200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. The intended use for each of the software's outputs is as follows: * The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. * The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. * The burst suppression parameters of this software (interburst interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

Source page: https://510kreport.com/device/K120485
Methodology: https://510kreport.com/methodology