# K121911: Octave Speeder Spine

- 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: 5 generations back to K002531 (2000). 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)
- K063361: Excelart Vantage Atlas, Model MRT-1503, Toshiba America Medical Systems, In.C (2006) Summary page 2.

## Indications for use
The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine. The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

Source page: https://510kreport.com/device/K121911
Methodology: https://510kreport.com/methodology