# K954354: Magnetic Resonance Diagnostic Accessory

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Apr 12, 1996 after 207 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 K892235 (1989). 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)
- K892235: GE Shoulder Surface Coil, Cat. #M1085AN, General Electric Co. (1989) Summary page 1.

## Indications for use
The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accommodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures.

Source page: https://510kreport.com/device/K954354
Methodology: https://510kreport.com/methodology