# K160935: 8ch Foot Ankle Coil

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen RF Tech Co., Ltd.
- Decided: Jul 28, 2016 after 115 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: 2 generations back to K050514 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122694: GE 8CH Foot Ankle Coil, Ge Hangwei Medical Systems Co., Ltd. (2012) Summary page 5.

## Indications for use
The 8ch Foot Ankle Coil is manufactured by RFT and is designed for use with GE 1.5T MRI systems in receive-only mode. It is indicated for foot and ankle imaging. The nucleus excited is hydrogen.

Source page: https://510kreport.com/device/K160935
Methodology: https://510kreport.com/methodology