# K031366: Premier 9000 8 Channel Phased Array CTL Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jul 11, 2003 after 72 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 K911806 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980157: Premier 7000 CTL Spine Coil, Usa Instruments, Inc. (1998) Summary page 2.

## Indications for use
The Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic: and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T scanner manufactured by GEi Medical Systems, Inc. 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 producles images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T I , 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 imiages yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K031366
Methodology: https://510kreport.com/methodology