GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102

K965044 · Elscint, Inc. · LNH · Jun 16, 1997 · Radiology

Device Facts

• Record ID: K965044
• Device Name: GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
• Applicant: Elscint, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Whole Body Magnet Resonance Imaging

Device Story

EPI (Echo Planar Imaging) is a software-based imaging sequence modification for Elscint Gyrex Prestige and Privilege MRI systems. It functions by generating multiple gradient echoes following an initial RF excitation, enabling faster image acquisition compared to standard gradient echo techniques. The device is operated by clinical staff within an MRI suite. Output consists of diagnostic MR images used by physicians for clinical assessment. The primary benefit is increased imaging speed, facilitating applications where rapid acquisition is required, despite inherent limitations in spatial resolution compared to slower sequences.

Clinical Evidence

No clinical data provided; effectiveness is based on the technical comparison of imaging sequences and the assertion that safety parameters remain within FDA-recommended limits.

Technological Characteristics

MRI imaging sequence modification. Operates within existing Gyrex Prestige and Privilege MRI hardware. Software level of concern is minor. No changes to electrical, mechanical, or biocompatibility specifications.

Indications for Use

Indicated for whole body magnetic resonance 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

• Gyrex 2T Prestige system (K945791)
• Gyrex Privilege system (K954039)

Submission Summary (Full Text)

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Elscint EPI for the Gyrex Prestige and Privilege Systems 510(k)
K965044
JUN 16 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

1. Device Name: EPI for the Gyrex Prestige and Privilege systems.
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. Device Modification Description

The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.

3. Predicate Devices: Gyrex 2T Prestige system (k945791), Gyrex Privilege system (k954039).

4. Safety

- The MRI safety parameters, SAR, dB/dt, $B_0$, and acoustic noise, are unchanged by the current modification.
- Electrical, mechanical, and biocompatibility safety issues do not apply to the current modification.
- No new software hazards have been introduced, so the software level of concern remains minor.
- The current modifications do not affect the site planning, installation, or service manuals, and do not require any new safety labeling.

5. Effectiveness

The EPI sequences produce images that are comparable with those produced using other imaging sequences. The EPI sequences are limited in resolution, but they are faster than other imaging sequences which makes them useful for particular applications.

6. Substantial Equivalency Statement

The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the modified devices is similar to that of the predicate devices. It is Elscint's opinion that the Prestige and Privilege systems with the new EPI sequences are substantially equivalent to their predicate devices in terms of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 16 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Beny Sherer
Safety Officer
Elscint, Inc.
86 Orchard Street
Hackensack, NJ 07601

Re: K965044
EPI for Gyrex Prestige and Privilege MRI Systems
Dated: March 24, 1997
Received: March 25, 1997
Regulatory Class: II
21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Sherer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): ___________________________

Device Name: EPI for the Gyrex Prestige and Privilege MRI Systems

Indications For Use:
Whole Body Magnet Resonance Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
(3(k) Number K965044)

Prescription Use ☑
(Per 21 CFR 801.109)

Over-The-Counter Use __________

(Optional Format 1-2-96)