# K954353: 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 K895794 (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)
- K895794: GE MR Max System, GE Medical Systems (1989) Summary page 1.

## Indications for use
The 0.2T Extremity Coil expands the capability of the 02T MR imaging system. It accommodates and improves imaging of the knee and surrounding structures. It can also be used to image other extremity body parts such as the ankle and wrist.

Source page: https://510kreport.com/device/K954353
Methodology: https://510kreport.com/methodology