# K122694: GE 8CH Foot Ankle Coil

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hangwei Medical Systems Co., Ltd.
- Decided: Oct 25, 2012 after 51 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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 K050514 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050514: Models Fac-63 and Fac-127 Foot and Ankle Coils, Mri Devices Corporation (2005) Summary page 1.

## Most influential descendants
- K160935: 8ch Foot Ankle Coil (2016), 0 descendants of its own

## Indications for use
The GE BCH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.

Source page: https://510kreport.com/device/K122694
Methodology: https://510kreport.com/methodology
