# K163644: Nihon Kohden QP-160AK EEG Trend Program

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: May 19, 2017 after 147 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: 9 generations back to K875179 (1988). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P, Nihon Kohden America, Inc. (2012) Summary page 4.
- K133793: Persyst 12 ( P12)  Egg Review and Analysis Software, Persyst Development Corporation (2014) Summary page 4.

## Indications for use
The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use 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. • The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert. 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/K163644
Methodology: https://510kreport.com/methodology