Who is the manufacturer of MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

GE Medical Systems filed the 510(k) submission for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K962061).

What is the FDA product code for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

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

What is the regulatory pathway for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

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

Who can help prepare an FDA 510(k) submission like MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

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.

MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K962061 · GE Medical Systems · LNH · Nov 27, 1996 · Radiology

Device Facts

Record ID	K962061
Device Name	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
Applicant	GE Medical Systems
Product Code	LNH · Radiology
Decision Date	Nov 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

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.

Indications for Use

Indicated for diagnostic imaging of head or body internal structures in patients requiring transverse, sagittal, coronal, or oblique MR imaging to visualize proton density, T1, T2, and flow properties.

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

Signa Horizon System

Related Devices

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K103238 — 1.5T OPTIMA MR430S · Ge Medical Systems, LLC · Feb 11, 2011
K161567 — SIGNA Voyager · GE Healthcare · Sep 1, 2016
K972826 — ESTEEM 1.5T MRI SYSTEM · Elscint Mr, Inc. · Oct 15, 1997

Submission Summary (Full Text)

{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.