GYREX V-EP

K962618 · Elscint, Inc. · LNH · Sep 4, 1996 · Radiology

Device Facts

• Record ID: K962618
• Device Name: GYREX V-EP
• Applicant: Elscint, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Device Story

Magnetic resonance diagnostic device; modification of Gyrex Privilege system; enables upgrade of Gyrex V-Dlx to Gyrex Privilege without magnet replacement; utilizes existing magnet; includes modified gradient coils and body coil; operated by trained personnel in clinical imaging environment; produces diagnostic MR images; performance specifications identical to predicate; safety parameters (SAR, dB/dt, acoustic noise) within IEC 601-2-33 limits.

Clinical Evidence

No clinical data; bench testing only. Safety analysis confirms SAR, dB/dt, and acoustic noise levels comply with IEC 601-2-33 final draft. Gradient and body coils comply with safety standards.

Technological Characteristics

Magnetic resonance diagnostic device; modified magnet, gradient coils, and body coil dimensions compared to predicate; patient-contacting materials identical to predicate; safety compliance per IEC 601-2-33.

Indications for Use

Indicated for magnetic resonance diagnostic imaging.

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

• Elscint Gyrex Privilege system (K954039)

Reference Devices

• Gyrex V-Dlx

Submission Summary (Full Text)

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K962618
SEP - 4 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

1. Device Name: Gyrex V-EP:

1.2 Classification Name: Magnetic Resonance Diagnostic Device

1.3 Submitter: Elscint, Inc., 505 Main St., Hackensack, NJ 07601

1.4 510(k) Number: _______________

2. Identification of Predicate Device: The predicate device is the Elscint Gyrex Privilege system (K954039).

3. Comparison to Predicate Device

The Gyrex V-EP is a modification of the Gyrex Privilege system that enables current owners of the Gyrex V-Dlx to upgrade to the Gyrex Privilege without having to replace their existing magnet. The differences between the Gyrex V-EP and the Standard Gyrex Privilege are the size of the magnet, the size of the gradient coils, and the size of the Body Coil. All performance specifications are identical in the two systems.

4. Safety Analysis

The Bo is the same as in the predicate device, and the SAR, dB/dt, and acoustic noise have changed, but remain below the levels of concern defined by the IEC 601-2-33 final draft. The gradient coils and Body Coil comply with appropriate safety standards.

All patient contacting materials in the Gyrex V-EP are identical to those in the predicate device, and no new safety hazards related to Site Planning, Installation, and Service, or requirements for safety related labeling were introduced.

5. Effectiveness Comparison

The performance specifications of the Gyrex V-EP are identical to those of the predicate device.

6. Substantial Equivalency Statement

It is Elscint's opinion that the Gyrex V-EP is substantially equivalent in safety and effectiveness to its predicate device.

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