# K041487: QD Head Speeder with Speeder NV Attachment

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Jun 17, 2004 after 13 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: 2 generations back to K964531 (1997). 3 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K001870: Millennium 9000 Phased Array Neurovascular Coil, Usa Instruments, Inc. (2000) Summary page 2.
- K022582: Excalibur 9000 Totalsense Quad Head Array Coil, Usa Instruments, Inc. (2002) Summary page 2.

## Most influential descendants
- K083160: 1.5T Atlas Speeder Head-Neck Coil (2008), 4 descendants of its own
- 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

## Indications for use
The QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The OD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc. Anatomic Regions: brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 1.5T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K041487
Methodology: https://510kreport.com/methodology