# K130457: 3T Distal Coil, 3T Elbow Coil, 3T Long Bone Coil

- Pathway: 510(k) (Special)
- Applicant: Resonance Innovations, LLC
- Decided: May 20, 2013 after 87 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) 1.5T ScanMed PV Array: named in the summary without a submission number

## Indications for use
The intended use for the device family is to provide form fitting MRI antenna sets to facilitate targeting imaging of various musculoskeletal extremity regions using a GE 3.OT MRI scanner. The Indications for use are: * Soft tissue and bone imaging of the extremities as allowed by the MRI system. * Magnetic resonance peripheral angiography.

Source page: https://510kreport.com/device/K130457
Methodology: https://510kreport.com/methodology