MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K963429 · GE Medical Systems · LNH · Nov 27, 1996 · Radiology

Device Facts

• Record ID: K963429
• Device Name: MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
• Applicant: GE Medical Systems
• Product Code: LNH · Radiology
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

SmartPrep IA option enables breath hold studies and trigger acquisition based on timing related to the arrival of a user injected exogenous contrast agent bolus.

Device Story

SmartPrep IA is an optional software modification for Signa Horizon MR systems; enables scan acquisition triggered by arrival of user-injected contrast bolus at a prescribed volume of interest; facilitates breath-hold studies; operated by MR technologists/radiologists in clinical imaging settings; output is automated scan triggering; benefits include improved timing of contrast-enhanced imaging and reduced motion artifacts.

Clinical Evidence

Bench testing only. Evaluation performed against IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Software functionality confirmed.

Technological Characteristics

Software-based imaging technique; modification to Fast Gradient Echo pulse sequence; integrates Infusion Advisor scan; operates within Signa Horizon MR system architecture.

Indications for Use

Indicated for patients undergoing MR imaging requiring breath hold studies and contrast-enhanced scan acquisition triggered by the arrival of an exogenous contrast agent bolus.

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 Horizon HiSpeed MR System

Submission Summary (Full Text)

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NOV 27 1996
K963429
GE Medical Systems
P.O. Box 414, W-709
Milwaukee, WI 53201
USA

# 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 16, 1996

- **Identification of the Product**
SmartPrep IA

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

- **Marketed Device**
The SmartPrep IA Option is a modification to the currently marketed Signa Horizon MR Systems.

- **Device Description**
The SmartPrep IA Option is an optional imaging technique that results in a scan acquisition being triggered off of the arrival of a user injected bolus of contrast agent at a prescribed volume of interest.

- **Indications for Use**
SmartPrep IA option enables breath hold studies and trigger acquisition based on timing related to the arrival of a user injected exogenous contrast agent bolus.

- **Comparison with Predicate**
The SmartPrep IA Option is substantially equivalent to the currently marketed Signa Horizon HiSpeed MR System. The Fast Gradient Echo pulse sequence is modified by the insertion of an Infusion Advisor scan.

- **Summary of Studies**
The SmartPrep IA Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Evaluation testing confirmed the functionality of the software.

- **Conclusions**
It is the opinion of GE that the SmartPrep IA Option is substantially equivalent to the currently marketed Signa Horizon Fast Gradient Echo pulse sequence. The option does not result in any new potential hazards.