# K022582: Excalibur 9000 Totalsense Quad Head Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Oct 22, 2002 after 78 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: 1 generation back to K964531 (1997). 2 ancestors in all.
6 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.
- K964531: Profile 70000 Quadrature Volume Neck Coil, Us Asia Instruments, Inc. (1997) Summary page 2.

## Most influential descendants
- K041487: QD Head Speeder with Speeder NV Attachment (2004), 5 descendants of its own
- 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

## Indications for use
The Excalibur 9000 TotalSENSETMQuad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSETMQuad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems. Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. 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/K022582
Methodology: https://510kreport.com/methodology