# K102889: Hitachi Echelon NV Attachment and Small Extremity Coils Model Echelon

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Dec 20, 2010 after 81 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-NVC-150N, RAPID Neurovascular (NV) Attachment Coil is a receive-only multiple array device used for MRI imaging of the upper spine and torso. It is designed to be used the Hitachi Echelon 1.5T MRI system. The MR-RWC-150N, RAPID Small Extremity Coil is a receive-only multiple array device used for MRI imaging of the extremities. It is designed to be used the Hitachi Echelon 1.5T MRI system.

Source page: https://510kreport.com/device/K102889
Methodology: https://510kreport.com/methodology