MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY

K954353 · General Electric Co. · LNH · Apr 12, 1996 · Radiology

Device Facts

• Record ID: K954353
• Device Name: MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
• Applicant: General Electric Co.
• Product Code: LNH · Radiology
• Decision Date: Apr 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 0.2T Extremity Coil expands the capability of the 0.2T MR imaging system. It accommodates and improves imaging of the knee and surrounding structures. It can also be used to image other extremity body parts such as the ankle and wrist.

Device Story

Quadrature receive-only MR coil; housed in biocompatible shell; includes adjustable positioning base and comfort pads. Used with 0.2T vertical magnetic field MR imaging systems. Operates as accessory to MR scanner; receives RF signals from extremity anatomy (knee, ankle, wrist). Output is raw MR signal processed by host scanner into diagnostic images. Used in clinical imaging environments by trained MR technologists/radiologists. Enhances image quality for extremity structures; aids clinical diagnosis of musculoskeletal conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological similarity to predicate device.

Technological Characteristics

Quadrature receive-only coil; biocompatible outer shell; adjustable positioning base; patient comfort pads. Designed for 0.2T vertical magnetic field MR systems.

Indications for Use

Indicated for patients requiring MR imaging of the knee, ankle, or wrist using a 0.2T vertical magnetic field MR imaging system.

Regulatory Classification

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 MR Max Plus Extremity Coil (K895794)

Submission Summary (Full Text)

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K954353
GE Medical Systems

APR 12 1996
0.2T Extremity 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: [phone]
Fax: [phone]

Product: 0.2T Extremity Coil
Manufactured by GE Yokogawa Medical System, Ltd.
Tokyo, Japan

1) **Indications for Use**
The 0.2T Extremity Coil expands the capability of the 0.2T MR imaging system. It accommodates and improves imaging of the knee and surrounding structures. It can also be used to image other extremity body parts such as the ankle and wrist.

2) **Device Description**
The 0.2T Extremity coil is a quadrature receive-only coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and patient comfort pads for support. It is designed specifically for use with a vertical magnetic field MR imaging system.

3) **Marketing History**
The 0.2T Extremity Coil has not been previously marketed by GE Medical Systems.

4) **Potential Adverse Effects on Health**
The use of the 0.2T Extremity 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 Extremity Coil is substantially equivalent to the presently marketed GE MR Max Plus Extremity Coil (#K895794).

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