# K980157: Premier 7000 CTL Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Apr 13, 1998 after 87 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 K911806 (1991). 2 ancestors in all.
65 later devices descend from it; 8 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932693: Edge System, Philips Medical Systems (Cleveland), Inc. (1993) Summary page 2.
- K911806: Magnetic Resonance Diagnostic Accessory, General Electric Co. (1991) Summary page 2.

## Most influential descendants
- K994345: Magna 5000 Phased Array CTL Spine Coil (2000), 51 descendants of its own
- K042236: G-SCAN (2004), 45 descendants of its own
- K060956: G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan XQ-Models-9800010011/9800010005,9800010009/9800010004 (2006), 43 descendants of its own
- K063207: S-Scan Mri System (2006), 34 descendants of its own
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera (2006), 32 descendants of its own

## Indications for use
The Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR’s Signa 1.5T scanner. Anatomic Regions: Spine Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa 1.5T 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/K980157
Methodology: https://510kreport.com/methodology