← Product Code [LNI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI) · K970005

# GYREX 2T-PRESTIGE (K970005)

_Elscint, Inc. · LNI · Mar 28, 1997 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K970005

## Device Facts

- **Applicant:** Elscint, Inc.
- **Product Code:** [LNI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI.md)
- **Decision Date:** Mar 28, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Device Story

Software addition to Gyrex 2T Prestige MRI system enabling 1H spectroscopy. Uses existing MRI hardware for data acquisition. Software performs automated shimming, water suppression, transmitter calibration, central frequency calibration, phase correction, and spectral processing. Operated by MRI technicians/radiologists in clinical imaging settings. Output consists of 1H spectra for diagnostic review by clinicians. Modification does not alter B0, dB/dt, acoustic noise, or SAR limits of base system.

## Clinical Evidence

No clinical data provided; effectiveness established via comparison to predicate device and bench testing of software safety.

## Technological Characteristics

Software-based 1H spectroscopy module for existing MRI hardware. Features automated shimming, water suppression, transmitter calibration, central frequency calibration, and phase correction. Operates within existing MRI safety limits (B0, dB/dt, SAR).

## 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

- Gyrex 2T Prestige System (k945791)
- GE Hydrogen Spectroscopy Option - PROBE (k930265)

## Submission Summary (Full Text)

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SUMMARY OF SAFETY AND EFFECTIVENESS

k970005

1. Device Name: Gyrex 2T Prestige $^1$H Spectroscopy Option.
1.2 Classification Name: Magnetic Resonance Diagnostic Device
1.3 Submitter: Elscint, Inc., 505 Main St., Hackensack, NJ 07601
1.4 510(k) Number: _______________.
MAR 28 1997

2. Identification of Predicate Devices: The predicate devices are the Gyrex 2T Prestige System (k945791) and the GE Hydrogen Spectroscopy Option - PROBE (k930265).

3. Modifications to Predicate Device

The current modification to the Gyrex 2T-Prestige consists of the addition of software to enable the production of $^1$H spectra. The spectra are produced using the existing MRI hardware.

The spectroscopy software includes automated shimming, water suppression, transmitter calibration, central frequency calibration, phase correction and display, and higher level spectral processing functions.

4. Safety Comparison

The $B_0$, $dB/dt$, and acoustic noise are unaffected by the current modification, and the maximum SAR is the same as for the predicate device.

All potential software safety hazards were minimized by controlled design, and testing.

No electrical, mechanical, biocompatibility, site planning, installation, or service hazards, or requirements for safety related labeling were introduced by this modification.

5. Effectiveness Comparison

The effectiveness of the system is similar to that of the GE Hydrogen Spectroscopy Option - PROBE (the predicate device).

6. Substantial Equivalency Statement

The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the device is similar to that of the predicate devices. It is Elscint's opinion that the 2T Prestige with the $^1$H Spectroscopy Option is substantially equivalent in safety and effectiveness to its predicate devices.

31-Oct-96

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K970005](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNI/K970005)

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