# K041263: Neuroguide Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Neuroscience, Inc.
- Decided: Aug 3, 2004 after 84 days
- Product code: OLU (Normalizing Quantitative Electroencephalograph Software)
- 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: 2 generations back to K801604 (1980). 15 ancestors in all.
21 later devices descend from it; 9 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844481: Neurolab II, Teca, Inc. (1985) Summary page 1.
- K890881: Teca 1A96, 1A97 and 1A98 Electroencephalographs, Teca, Inc. (1989)
- K894889: Teca Neuromapper 386, Teca, Inc. (1989) Summary page 1.
- K801604: Pathfinder Electrodiagnostic System, Nicolet Biomedical Instruments (1980) Summary page 1.
- K843598: Brain Function Mapping Option for Pathf, Nicolet Biomedical Instruments (1985) Summary page 1.
- K860801: Model 8400 W/Modifications (Spectrum 32), Cadwell Laboratories, Inc. (1986) Summary page 1.
- K904269: Neurosearch-24 or NRS-24, Lexicor Medical Technology, Inc. (1991) Summary page 1.
- K920038: Neurosearch-4, Lexicor (1995) Summary page 1.
- K850430: Neuroscience Map-10 Eeg, Neuroscience, Inc. (1985). Our OCR of the scanned summary read K840430, FDA’s number for Sun-Lite White Slit (Suncoast Medical Manufacturers, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Neuroscience, Inc. Map-10 EEG”.
- K870263: Neuromapper 1620, Neuroscience, Inc. (1987) Summary page 1.
- K854362: Modified Brain Atlas Iii, Bio-Logic Systems Corp. (1986) Summary page 1.
- K951594: Bio-Logic Automatic Event Analysis, Bio-Logic Systems Corp. (1995) Summary page 1.
- K904294: QSI 9500, Quantified Signal Imaging, Inc. (1991) Summary page 1.
- K912938: Rhythm, Stellate Systems (1991) Summary page 1.
- K974748: Neurometric Analysis System, Nxlink, Ltd. (1998) Summary page 1.
- (no number) Cordis Brain State Analyzer: named in the summary without a submission number
- (no number) Nicolet BEAM I, II: named in the summary without a submission number
- (no number) QS1-9200: named in the summary without a submission number

## Most influential descendants
- K092039: Identevent, Version 1.0G (2009), 9 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K171414: qEEG-Pro (2018), 4 descendants of its own
- K050192: BRC Software Product (2005), 4 descendants of its own

## Indications for use
For clinical use the NeuroGuide Analysis system is to be used by qualified medical or clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).

Source page: https://510kreport.com/device/K041263
Methodology: https://510kreport.com/methodology