# K083086: Echelon High Resolution Foot Coil (MR-HRF-150), Echelon Long Bone Coil (MR-LBC-150)

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Dec 5, 2008 after 50 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. The FDA summary names its predicate without a number.
- (no number) ECHELON RAPID Foot Coil: named in the summary without a submission number

## Indications for use
The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple array device used for MRI imaging of the ankle. The MR-LBC-150, ECHELON Long Bone Coil is a receive-only multiple array device used for MRI imaging of the extremities.

Source page: https://510kreport.com/device/K083086
Methodology: https://510kreport.com/methodology