# K122638: Toshiba 3T 32CH Head Speeder Coil,

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics
- Decided: Sep 25, 2012 after 27 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083160: 1.5T Atlas Speeder Head-Neck Coil, Quality Electrodynamics (2008) Summary page 2.

## Indications for use
The Toshiba 3T 32CH Head SPEEDER Coil is intended for use with the Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the head that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K122638
Methodology: https://510kreport.com/methodology