# K083160: 1.5T Atlas Speeder Head-Neck Coil

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics
- Decided: Nov 7, 2008 after 11 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 K964531 (1997). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041487: QD Head Speeder with Speeder NV Attachment, Usa Instruments, Inc. (2004) Summary page 1.

## Most influential descendants
- K142802: Atlas SPEEDER Head/Neck (2014), 1 descendant of its own
- K151829: Atlas SPEEDER Header/Neck (2015), 0 descendants of its own
- K122638: Toshiba 3T 32CH Head Speeder Coil, (2012), 0 descendants of its own
- K093667: Shoulder Speeder Coil (2010), 0 descendants of its own

## Recalls of this device
- Dec 29, 2008 · Not classified · Z-1938-2009: The firm received a complaint indicating that the mirror is high risk and could drop on a patient.

## Indications for use
For use with a Toshiba Excelart Vantage Atlas or Vantage Titan MR scanner to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K083160
Methodology: https://510kreport.com/methodology