# K093667: Shoulder Speeder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics
- Decided: Jan 28, 2010 after 62 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
Longest line of descent: 4 generations back to K964531 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945778: Phased Array Shoulder Coil, Quadrature Shoulder Coil, Medical Advances, Inc. (1995) Summary page 2.
- K083160: 1.5T Atlas Speeder Head-Neck Coil, Quality Electrodynamics (2008) Summary page 2.

## Indications for use
For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K093667
Methodology: https://510kreport.com/methodology