← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K954354

# MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K954354)

_General Electric Co. · LNH · Apr 12, 1996 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K954354

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md)
- **Decision Date:** Apr 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Indications for Use

The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accommodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures.

## Device Story

Receive-only, linear, circular solenoidal MRI coil; housed in biocompatible shell; includes adjustable positioning base and comfort pads. Used in clinical MRI settings by trained technologists/radiologists. Device functions as signal receiver for 0.2T MR imaging systems to improve image quality of cervical spine, neck, and shoulder anatomy. Output is raw MR signal processed by host system into diagnostic images for physician interpretation. Benefits include enhanced anatomical visualization for clinical decision-making.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Receive-only, linear, circular solenoidal coil; biocompatible outer shell; includes adjustable positioning base and comfort pads. Designed for 0.2T MR imaging systems.

## Regulatory Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

## Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Predicate Devices

- GE Shoulder Surface Coil ([K892235](/device/K892235.md))

## Submission Summary (Full Text)

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K954354
GE Medical Systems
General Electric Company
PO Box 414, Milwaukee, WI 53201

APR 12 1996

0.2T GP Neck/Shoulder Coil

September 14, 1995

General Electric Medical Systems

SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

Contact: Larry A. Kroger
Phone: 414-544-3894
Fax: 414-544-3863

Product: 0.2T GP Neck/Shoulder Coil
Manufactured by GE Yokogawa Medical System, Ltd.
Tokyo, Japan

1) Indications for Use
The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accommodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures.

2) Device Description
The 0.2T GP Neck/Shoulder Coil is a receive-only, linear, circular solenoidal coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and comfort pads for support.

3) Marketing History
The 0.2T GP Neck/Shoulder Coil has not been previously marketed by GE Medical Systems.

4) Potential Adverse Effects on Health
The use of the 0.2T GP Neck/Shoulder Coil does not result in any additional potential hazards compared to previously marketed receive-only surface coils.

5) Conclusions
It is the opinion of GE Medical Systems that the 0.2T GP Neck/Shoulder Coil is substantially equivalent to the presently marketed GE Shoulder Surface Coil (#K892235).

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K954354](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K954354)

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