Who is the manufacturer of GYREX 2T-PRESTIGE?

Elscint, Inc. filed the 510(k) submission for GYREX 2T-PRESTIGE (K970005).

What is the FDA product code for GYREX 2T-PRESTIGE?

LNI. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for GYREX 2T-PRESTIGE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GYREX 2T-PRESTIGE?

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

Who can help prepare an FDA 510(k) submission like GYREX 2T-PRESTIGE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GYREX 2T-PRESTIGE

K970005 · Elscint, Inc. · LNI · Mar 28, 1997 · Radiology

Device Facts

Record ID	K970005
Device Name	GYREX 2T-PRESTIGE
Applicant	Elscint, Inc.
Product Code	LNI · Radiology
Decision Date	Mar 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

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).

Indications for Use

Indicated for patients undergoing magnetic resonance imaging requiring 1H spectroscopy for diagnostic evaluation.

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

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

Related Devices

K991568 — MR SPECTROSCOPY PACKAGE · Philips Medical Systems (Cleveland), Inc. · Jul 19, 1999
K071506 — ECHELON SPECTROSCOPY PACKAGE · Hitachi Medical Systems America, Inc. · Jun 28, 2007
K120315 — SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION · Siemens Medical Solutions USA, Inc. · Apr 13, 2012
K093044 — OASIS MRI SYSTEM · Hitachi Medical Systems America, Inc. · Mar 16, 2010
K220589 — MAGNETOM Skyra Fit · Siemens Medical Solutions USA, Inc. · May 13, 2022

Submission Summary (Full Text)

{0} 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