# K121910: Octave Speeder Head

- Pathway: 510(k) (Special)
- Applicant: Toshiba Medical Systems Corporation, Japan
- Decided: Aug 17, 2012 after 49 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: 6 generations back to K002531 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083014: Atlas Speeder Head/Cervical Coil, Model Mjah-137A, Toshiba America Medical Systems, In.C (2008) Summary page 2.

## Indications for use
The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest. The MJAH-167A is intended to be used on a Toshiba 1.5T MR System

Source page: https://510kreport.com/device/K121910
Methodology: https://510kreport.com/methodology