# K030540: HTS Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Jockey Club Mri Engineering Center
- Decided: Apr 16, 2003 after 55 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
MRI array coil for human extremities imaging Anatomical region: Anatomies in human extremities that have cross sectional diameter no larger than 4''

Source page: https://510kreport.com/device/K030540
Methodology: https://510kreport.com/methodology