# K151829: Atlas SPEEDER Header/Neck

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics, LLC
- Decided: Jul 29, 2015 after 23 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 K964531 (1997). 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)
- K142802: Atlas SPEEDER Head/Neck, Quality Electrodynamics, LLC (2014) Summary page 4.

## Indications for use
The Atlas SPEEDER Head/Neck is intended for use with Toshiba 3T MR systems to produce diagnostic images of the head, neck, and feet that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K151829
Methodology: https://510kreport.com/methodology