# K013595: Premier Iii Phased Array CTL Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jan 22, 2002 after 84 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.
3 later devices descend from it; 3 cite it directly.
0 of 8 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.
- K994345: Magna 5000 Phased Array CTL Spine Coil, Usa Instruments, Inc. (2000) Summary page 2.

## Most influential descendants
- K032538: 3.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array Coil (2003), 0 descendants of its own
- K032474: 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil (2003), 0 descendants of its own
- K031056: Modification to Premier Iii Phased Array CTL Spine Coil (2003), 0 descendants of its own

## Indications for use
The Premier I.I( Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier [li Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner. Anatomic Regions: Spine Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Medical Systems 3.0Tesla 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/K013595
Methodology: https://510kreport.com/methodology