← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K962061 # MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K962061) _GE Medical Systems · LNH · Nov 27, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K962061 ## Device Facts - **Applicant:** GE Medical Systems - **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md) - **Decision Date:** Nov 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. ## Device Story Signa Horizon Cx Magnetic Resonance System; utilizes superconducting magnet to acquire 2D single-slice, multi-slice, and 3D volume images. Pulse sequences include inversion recovery, spin echo, gradient echo, gradient recalled, and steady state free precession. Imaging options include cardiac/peripheral gating, flow compensation, and fat/water suppression to reduce motion artifacts. Stationary or mobile configuration. Operated by trained professionals in clinical settings. Output: MR images representing proton density, T1, T2, and flow. Physician interprets images to assist in clinical diagnosis. ## Clinical Evidence Bench testing only. System evaluated against NEMA performance standards and IEC 601-1 international medical equipment safety standard. No clinical data presented. ## Technological Characteristics Superconducting magnet system (1.5T and 1.0T). Pulse sequences: inversion recovery, spin echo, gradient echo, gradient recalled, steady state free precession. Imaging features: cardiac/peripheral gating, flow compensation, fat/water suppression. Stationary or mobile form factor. Compliant with NEMA standards and IEC 601-1. ## 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 - Signa Horizon System ## 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} NOV 27 1996 K962061 GE Medical Systems Page 1 of 2 P.O. Box 414, W-709 Milwaukee, WI 53201 USA # SUMMARY OF SAFETY AND EFFECTIVENESS - This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). - **Identification of Submitter** Larry A. Kroger, Ph.D., 414-544-3894, May 24, 1996 - **Identification of the Product** Signa Horizon Cx Magnetic Resonance System Manufactured by: GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188 - **Marketed Devices** The Signa Horizon Cx MR System with new 1.5T and 1.0T magnets is substantially equivalent to the currently marketed Signa Horizon System (software and electronics). - **Device Description** The Signa Horizon Cx System utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. A wide variety of pulse sequences is provided to the operator, including inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, free precession acquisitions. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system can be used as a stationary or mobile system. - **Indications for Use** The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. {1} page 2 of 2 GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA # SUMMARY OF SAFETY AND EFFECTIVENESS - **Comparison with Predicate** The magnets used with the Signa Horizon Cx System are 2 Tons lighter and have a lower cryogen boil off rate than the Signa Horizon magnets. The new magnets are also 68 cm shorter that the Horizon magnets. - **Summary of Studies** The Signa Horizon Cx System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. The Signa Horizon Cx System is comparable to the Signa Horizon MR Systems. - **Conclusions** It is the opinion of GE that the Signa Horizon Cx System is substantially equivalent to the Signa Horizon MR Systems. The Signa Horizon Cx does not include any new indications for use, nor does use of this device result in any new potential hazards. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K962061](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K962061) **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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