← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K964306

# MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K964306)

_General Electric Co. · LNH · Jan 17, 1997 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K964306

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md)
- **Decision Date:** Jan 17, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Intended Use

The Signa SP Flexible Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.

## Device Story

Signa SP Flex Coils; symmetric transmit/receive surface coils; helmholtz pair configuration; flexible, biocompatible outer covering. Used with Signa SP MR System; facilitates imaging of irregular anatomy; enables static or dynamic (joint/spine flexion) MRI. Operated by MRI technicians/radiologists in clinical imaging environments. Output: MR image data for diagnostic interpretation by physicians. Benefit: improved imaging of non-planar anatomy and dynamic joint movement.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Symmetric transmit/receive surface coils; helmholtz pair configuration; flexible biocompatible outer covering; dimensions vary by model; passive RF coil technology.

## 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

- Signa SP MR System ([K942604](/device/K942604.md))

## Submission Summary (Full Text)

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JAN 17 1997
GE Medical Systems
General Electric Company
P.O. Box 454, Milwaukee, WI 53201
K964306

# Signa SP Flex Coils

October 28, 1996

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, Ph.D.
Phone: 414-544-3894
FAX: 414-544-3863

Product: Signa SP Flex Coils
Manufactured by General Electric Medical Systems
Waukesha, Wisconsin, USA

1) Indications for Use

The Signa SP Flexible Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.

2) Device Description

The Signa SP Flex Coils are a group of symmetric transmit/receive surface coils of varying dimensions that are coupled as helmholtz pairs and contained in a flexible, biocompatible outer covering.

3) Marketing History

The Signa SP Flex Coils have not been previously marketed by GE Medical Systems.

4) Potential Adverse Effects on Health

The use of the Signa SP Flex Coils does not result in any additional potential hazards compared to previously marketed flexible transmit/receive surface coils.

5) Conclusions

It is the opinion of GE Medical Systems that the Signa SP Flex Coils are substantially equivalent to the presently marketed transmit/receive flexible surface coil contained in the Signa SP MR System (K942604).

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K964306](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K964306)

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