# K112366: 4CH Flex Speeder

- Pathway: 510(k) (Special)
- Applicant: Toshiba Medical Systems Coporation, Japan
- Decided: Sep 15, 2011 after 29 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). 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)
- K111251: 4CH Flex Speeder, Toshiba Medical Systems Coporation, Japan (2011) Summary page 2.

## Indications for use
Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis). MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.

Source page: https://510kreport.com/device/K112366
Methodology: https://510kreport.com/methodology