# K980477: Image Vue Eeg

- Pathway: 510(k) (Traditional)
- Applicant: Sam Technology, Inc.
- Decided: Aug 6, 1998 after 181 days
- Product code: OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph)
- 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 K843598 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960071: Imagefusion, Radionics Software Applications, Inc. (1996) Summary page 1.
- K843598: Brain Function Mapping Option for Pathf, Nicolet Biomedical Instruments (1985) Summary page 1.
- K970951: Grass Brainwave Software, Astro-Med, Inc. (1997) Summary page 1.

## Indications for use
The software is intended for use by a qualified/trained EEG technologist or physician on both adult and pediatric subjects for the visualization of human brain electrical activity by fusing a variety of EEG information with MRI images.

Source page: https://510kreport.com/device/K980477
Methodology: https://510kreport.com/methodology