# K974748: Neurometric Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Nxlink, Ltd.
- Decided: Jul 10, 1998 after 203 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: 1 generation back to K801604 (1980). 13 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 43 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.
- 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.
- (no number) Cordis Brain State Analyzer: named in the summary without a submission number
- (no number) Nicolet BEAM L 1I: named in the summary without a submission number
- (no number) Quantified Signal Imaging, Inc. QSI-9200: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K850881: Alba Dry Burn Pad, Alba Health Care (1985). Our OCR of the scanned summary read K850881, FDA’s number for Alba Dry Burn Pad (Alba Health Care). Its FDA name has none of the distinctive words the summary uses for the device it names, “Brain Mapper”. Kept off the family tree.

## Most influential descendants
- K041263: Neuroguide Analysis System (2004), 21 descendants of its own
- 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
- K161068: Ahead 300 (2016), 6 descendants of its own
- K181179: BrainScope One (2018), 5 descendants of its own

## Indications for use
The Neurometric Analysis System (NAS) is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG).

Source page: https://510kreport.com/device/K974748
Methodology: https://510kreport.com/methodology