# K244054: 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics
- Decided: Feb 28, 2025 after 59 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: 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 5.

## Indications for use
The 16CH Flex SPEEDER Medium is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician. The 16ch Flex SPEEDER Large coil is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K244054
Methodology: https://510kreport.com/methodology