# K200477: Flex Body Speeder

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics, LLC
- Decided: Apr 8, 2020 after 41 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 K933659 (1993). 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)
- K193140: Flex Body SPEEDER, Quality Electrodynamics, LLC (2020) Summary page 4.

## Indications for use
The Flex Body SPEEDER 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/K200477
Methodology: https://510kreport.com/methodology