# K050514: Models Fac-63 and Fac-127 Foot and Ankle Coils

- Pathway: 510(k) (Traditional)
- Applicant: Mri Devices Corporation
- Decided: Mar 25, 2005 after 24 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
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162177: dS FootAnkle I6CH 1.5T Coil (2016), 2 descendants of its own
- K213766: dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T (2021), 1 descendant of its own
- K151653: 8ch Foot Ankle Coil (2015), 1 descendant of its own
- K122694: GE 8CH Foot Ankle Coil (2012), 1 descendant of its own
- K262294: dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T (2026), 0 descendants of its own

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K050514
Methodology: https://510kreport.com/methodology