# K141832: 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil, LLC
- Decided: Jul 31, 2014 after 24 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K101632 (2010). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121362: 1.5T 16CH Flex Speeder Large, Neocoil, LLC (2012) Summary page 3.

## Recalls of this device
- Jun 17, 2016 · Class II · Z-2312-2016: There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.

## Indications for use
To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K141832
Methodology: https://510kreport.com/methodology