# K042186: 3.0T 8-Channel CTL Spine Array

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Aug 26, 2004 after 14 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: 3 generations back to K911806 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030042: Premier Iii Phased Array CTL Spine Coil, Usa Instruments, Inc. (2003) Summary page 2.

## Indications for use
The 3.OT 8-Channel CTL Spine Array is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 8-Channel CTL Spine Array is designed for use with the Siemens 3.0T scanner manufactured by Siemens Medical Systems, Inc. The indications for use are the same as for standard imaging: The 3.OT 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/K042186
Methodology: https://510kreport.com/methodology