← Product Code [LNH](/productcode/LNH) · K974614 # GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 (K974614) _Elscint, Inc. · LNH · Mar 4, 1998 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K974614 ## Device Facts - **Applicant:** Elscint, Inc. - **Product Code:** [LNH](/productcode/LNH.md) - **Decision Date:** Mar 4, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The production of a series of images of the heart at different phases of the cardiac cycle. ## Device Story Retrospective Gating is a software modification for Elscint MRI systems (Gyrex 2T Prestige, Privilege, and Prima 1 TG). Unlike standard cardiac gating, which triggers acquisition via the QRS pulse, this system performs continuous scanning. ECG data is correlated with the cardiac cycle post-acquisition. The device is operated by clinical staff in an MRI suite. The output consists of cardiac images at various cycle phases, enabling clinicians to visualize heart motion. This approach maintains existing MRI safety parameters (SAR, dB/dt, Bo, acoustic noise) and provides diagnostic images comparable to standard gating techniques without requiring hardware changes. ## Clinical Evidence No clinical data provided. Effectiveness is based on bench testing demonstrating that the retrospective gating option produces images comparable to those generated by standard cardiac gating techniques. ## Technological Characteristics Software-based cardiac gating modification for existing MRI systems. Operates via continuous scan acquisition with post-acquisition correlation to the ECG QRS cycle. No changes to hardware, materials, or energy sources. Software level of concern is minor. Connectivity and interoperability are consistent with existing Elscint MRI system specifications. ## 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](/device/K945791.md)) - Gyrex Privilege System ([K954039](/device/K954039.md)) - Gyrex Prima 1 TG System ([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}------------------------------------------------ ## 510(k) Summary # K974614 - 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 MAR - 4 1998 10 December 1997 Date of Summary: - Retrospective Gating for Elscint MRI Systems 2. Device Name: Retrospective Gating for Elscint MRI System Trade/Proprietary Name: MRI System Modification Common Name: Magnetic Resonance Diagnostic Device Classification Name: - Gyrex 2T Prestige system (K945791), Gyrex Privilege 3. Predicate Device(s): System (K954039), Gyrex Prima 1 TG System (K970990) #### 4. Device Description: The modification is a cardiac gating technique referred to as Retrospective Gating. In standard cardiac gating, the acquisition is triggered by the QRS pulse of the ECG. In Retrospective Gating, the scan runs continuously, and the correlation with the QRS cycle is done after the fact. This modification does not involve any changes to the existing hardware of the predicate devices. #### 5. Intended Use: | Anatomical Region: | Heart | |--------------------|--------------------------------------------------------------------------------------------| | Nuclei Excited: | Hydrogen | | Diagnostic Use: | Production of a series of images of the heart at different
phases of the cardiac cycle. | #### 6. Safety: - The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, are unchanged by the . current modification. - Electrical, mechanical, and biocompatibility safety issues are unchanged by the current . modification. - No new software hazards have been introduced, so the software level of concern remains . minor. - The current modification does not affect the site planning, installation, or service . manuals, and do not require any new safety labeling. {1}------------------------------------------------ #### 7. Effectiveness: The MRI performance parameters remain unchanged. The Retrospective Gating option produces images that are comparable with those produced using the standard cardiac gating technique. ### 8. Equivalency Information Summary: 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, Privilege and Prima systems with the new Retrospective Gating option are substantially equivalent to their predicate devices in terms of safety and effectiveness. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Beny Sherer Safety Officer Elscint, Inc. 86 Orchard Street Hackensack, NJ 07601 Re: K974614 MAR - 4 1998 Gyrex 2T Prestige, Privilege and Prima ITG with Retrospective Gating Dated: December 10, 1997 Received: December 11, 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 Fecteral 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 (21 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. 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 (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/odrh/dsmaldsmamain.html". Sincerely yours, Kilian Yih Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Far. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known):_K 974614 Device Name: Retrospective Gating for Elscint MRI Systems Indications For Use: The production of a series of images of the heart at different phases of the cardiac cycle. (Please do not write below this line - continue on another page if needed) (Concurrence of CDRH, Office of Device Evaluation (ODE)) Schmid C. Seyfarth (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number Prescription Use (Per 21 CFR 801.109) ( OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda-staging.innolitics.com/device/K974614](https://fda-staging.innolitics.com/device/K974614) **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. 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