# K033867: GE Brainwave Option (S) for Mri Systems

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Dec 19, 2003 after 7 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K003947 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003947: Functional Brain Mapping Option for Mri, GE Medical Systems (2001) Summary page 1.

## Indications for use
The GE Functional Brain Mapping Option is a software and hardware package that can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI scan studies taken in the presence of synchronized stimuli presented to a person being scanned. When interpreted by a trained physician these results may be useful in the determination of a course of treatment.

Source page: https://510kreport.com/device/K033867
Methodology: https://510kreport.com/methodology