← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K980306 # GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP (K980306) _Elscint, Inc. · LNH · Apr 2, 1998 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K980306 ## Device Facts - **Applicant:** Elscint, Inc. - **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md) - **Decision Date:** Apr 2, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use Whole Body and Organ Specific imaging The production of Magnetic Resonance Images ## Device Story Elscint MRI Software Version 3.0 is an update for existing Gyrex MRI systems. It introduces new imaging sequences (FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, diffusion weighted imaging), automated image filtering, multi-planar reconstruction (MPR), PCA color-coded velocity maps, time-lapse post-processing, real-time localizer, double oblique localization, and multiple presaturation. The device processes hydrogen nuclei signals to produce diagnostic MR images. Operated by trained clinical staff in a radiology setting, the software enhances image acquisition and post-processing capabilities. Output is viewed by clinicians to assist in diagnostic decision-making. The update improves system performance parameters, such as minimum TE, TR, FOV, and acquisition matrix resolution, compared to predicate versions, while maintaining safety limits for SAR, dB/dt, and acoustic noise. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on bench testing, design reviews, and code reviews to ensure software safety and performance consistency with predicate devices. ## Technological Characteristics MRI system software update. Features include advanced imaging sequences (FSAGE, EPI, FSE, SSE, SSV, diffusion weighted), automated image filtering, MPR, and velocity mapping. Connectivity is integrated into the existing MRI system architecture. Software safety verified through design and code reviews. No hardware modifications affecting system performance parameters. ## 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 ([K945791](/device/K945791.md)) - Gyrex Privilege ([K954039](/device/K954039.md)) - Gyrex V-EP ([K962618](/device/K962618.md)) - Gyrex Prima 1TG ([K970990](/device/K970990.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 1. Submitter's Name and Address: Elscint, Inc., 505 Main Street, Hackensack, NJ 07601 Contact Person and Telephone No.: Steven M. Kay, (201) 342-2020 Date of Summary: 11 January, 1998 APR - 2 1998 | Device Name: | Elscint MRI Software Version 3.0 | |-------------------------|--------------------------------------| | Trade/Proprietary Name: | Elscint MRI Software Version 3.0 | | Common Name: | MRI System | | Classification Name: | Magnetic Resonance Diagnostic Device | Gyrex 2T Prestige (k945791), 3. Predicate Device(s): Gyrex Privilege (k954039), Gyrex V-EP (k962618), Gyrex Prima 1TG (k970990) ### 4. Device Description: The modifications include: new imaging sequences: FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, and diffusion weighted imaging, automated image filtering, MPR, PCA color coded velocity maps, Time Lapse post processing, Real-Time Localizer, double oblique localization, and multiple presaturation. ### 5. Intended Use: | Anatomical Region: | Whole Body and Organ Specific imaging | |--------------------|---------------------------------------------| | Nuclei Excited: | Hydrogen | | Diagnostic Use: | The production of Magnetic Resonance Images | ## 6. Safety: The SAR, dB/dt, acoustic noise, and Bo are the same as the predicate devices. All potential software safety hazards were minimized by design reviews, code reviews, and testing. {1}------------------------------------------------ ## 7. Effectiveness: # Acquisition Parameter Comparison | | Version 3.0 | Predicate Devices | |-------------------------------|------------------------|------------------------| | Minimum TE | 2ms | 4.3ms | | Minimum TR | 7ms | 11ms | | Minimum FOV | 4cm | 6.4cm | | Maximum 2D Acquisition Matrix | $1024^2$ | $512^2$ | | Maximum 3D Acquisition Matrix | $256^3$ or 128x512x512 | $256^3$ or 128x512x512 | | Maximum Number of Echoes | 8 | 8 | | Maximum Number of Slices | 80 | 80 | | Minimum Slice Width | 0.5mm | 0.7mm | The system performance parameters are not protocol dependent, and no acquisition software or hardware modifications which affect the system performance parameters are included in Version 3.0. The system performance parameters are therefore not affected by the current modification. # 8. Equivalency Information Summary: The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the devices is improved in non-substantial ways from that of the predicate devices. It is Elscint's opinion that the Elscint MRI Systems with Software Version 3.0 are substantially equivalent in safety and effectiveness to their predicate devices. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint. Inc. 505 Main Street Hackensack, NJ 07601 Re: K980306 APR - 2 1998 · Software Version 3.0 for the Gyrex Magnetic Resonance Imaging Systems Dated: January 23, 1998 Received: January 27, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH Dear Mr. Kay: 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 ensement date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Councilic 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 and prohibitions against misbranding and adulteration. If your device is classified (see above) into either 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS 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 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmala.html". Sincerely yours, Lillian Yin, Ph.D. 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 {3}------------------------------------------------ K48 030 6 510(k) Number (if known): VERSION 3.0 Device Name: _ Indications For Use: MAGNETIC RESONANCE IMAGINE BODY WHOLE (Please do not write below this line-continue on another page if needed) (Concurrence of CDRH, Office of Device Evaluation(ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_ Kermit C. Biegner OR (Division Sign-Off) … Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number K960306 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K980306](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K980306) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com