MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K963179 · GE Medical Systems · LNH · Nov 7, 1996 · Radiology

Device Facts

• Record ID: K963179
• Device Name: MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
• Applicant: GE Medical Systems
• Product Code: LNH · Radiology
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Signa SP System optional accessories are indicated for use as follows: - The Scan Plane Pointer facilitates localization of the scanning planes. - The side entry patient support access feature and the Patient Imaging Chair allows multiple patient positions enabling imaging exams of dynamic joints (such as knees and shoulders) and loaded spine studies. - The use of MR Imaging during interventional procedures using common devices such as fine needles and suction.

Device Story

Signa SP Magnetic Resonance System accessories; includes Scan Plane Pointer, Patient Imaging Chair, and side-docking patient support table. Open magnet configuration reduces patient anxiety; facilitates patient positioning and access. Scan Plane Pointer localizes scanning planes; images displayed to operator and at table-side. Enables dynamic joint imaging and loaded spine studies; supports interventional procedures using needles/suction. Used in clinical MR environments by trained medical personnel. Enhances imaging functionality and patient access compared to base Signa SP system.

Clinical Evidence

Bench testing only. Evaluated against NEMA performance standards and IEC 601-1 international medical equipment safety standard. Testing confirmed accuracy statements in the User Manual.

Technological Characteristics

Open magnet MR system configuration. Accessories include mechanical patient support chair, side-docking table, and scan plane pointer. Complies with IEC 601-1 safety standards and NEMA performance standards.

Indications for Use

Indicated for patients requiring MR imaging of dynamic joints (knees, shoulders) and loaded spine studies, and for patients undergoing interventional procedures using common devices like needles and suction.

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

• Signa SP System

Submission Summary (Full Text)

{0}

g

K963179

GE Medical Systems

ge 1 of 2

P.O. Box 414, W-709
Milwaukee, WI 53201
USA

NOV - 7 1996

# SUMMARY OF 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).

- **Identification of Submitter**
Larry A. Kroger, Ph.D., 414-544-3894, August 2, 1996

- **Identification of the Product**
Signa SP Magnetic Resonance System - Optional Accessories

Manufactured by:
GE Medical Systems
3200 N. Grandview Blvd.
Waukesha, WI 53188

- **Marketed Devices**
The Signa SP Magnetic Resonance System with optional accessories is substantially equivalent to the currently marketed Signa SP System.

- **Device Description**
The Signa SP System employs an open magnet configuration which helps to reduce patient anxiety, increases patient positioning options and allows easy access to the patient. The Scan Plane Pointer accessory is useful in acquiring MR images relative to the physical orientation of the patient. The images may then be displayed to the operator and on a screen at table side.

- **Indications for Use**
The Signa SP System optional accessories are indicated for use as follows:
- The Scan Plane Pointer facilitates localization of the scanning planes.
- The side entry patient support access feature and the Patient Imaging Chair allows multiple patient positions enabling imaging exams of dynamic joints (such as knees and shoulders) and loaded spine studies.
- The use of MR Imaging during interventional procedures using common devices such as fine needles and suction.

{1}

GE Medical Systems

ge 2 of 2

P.O. Box 414, W-709

Milwaukee, WI 53201

USA

# SUMMARY OF SAFETY AND EFFECTIVENESS

- **Comparison with Predicate**

The Signa SP Magnetic Resonance System with optional accessories, namely the Patient Support Chair, side docking of the patient support table and the Scan Plane Pointer give more imaging functionality.

- **Summary of Studies**

The Signa SP optional accessories was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. Evaluation testing confirmed accuracy statements in the User Manual.

- **Conclusions**

It is the opinion of GE that the Signa SP optional accessories is substantially equivalent to the Signa SP Systems. The optional accessories do not result in any new potential hazards.