Who is the manufacturer of MAGNETIC RESONANCE DIAGNOSTIC SYSTEM?

GE Medical Systems filed the 510(k) submission for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K964370).

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

K964370 · GE Medical Systems · LNH · Jan 10, 1997 · Radiology

Device Facts

Record ID	K964370
Device Name	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
Applicant	GE Medical Systems
Product Code	LNH · Radiology
Decision Date	Jan 10, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The Signa Contour 2 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 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 Contour 2 is a 0.5T magnetic resonance imaging (MRI) system; utilizes superconducting magnet to acquire 2D single-slice, multi-slice, and 3D volume images. Operator selects pulse sequences including 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 mitigate motion artifacts. System operates in stationary or mobile configurations. Physician interprets resulting images to determine diagnosis based on spatial distribution of hydrogen nuclei. Benefits include diagnostic visualization of internal anatomy.

Clinical Evidence

Bench testing only. System evaluated against NEMA performance standards and IEC 601-1 international medical equipment safety standards. No clinical data provided.

Technological Characteristics

0.5T superconducting magnet; zero cryogen boil-off; supports 2D/3D imaging; 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.

Indications for Use

Indicated for diagnostic imaging of internal head or body structures in patients requiring MR examination; produces transverse, sagittal, coronal, and oblique images based on 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 Contour System

Related Devices

K962061 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEM · GE Medical Systems · Nov 27, 1996
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K992135 — SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM · Ge Medical Systems, Inc. · Sep 8, 1999
K972826 — ESTEEM 1.5T MRI SYSTEM · Elscint Mr, Inc. · Oct 15, 1997
K992746 — SIGNA HFO/I MAGNETIC RESONANCE SYSTEM · Ge Medical Systems, Inc. · Nov 9, 1999

Submission Summary (Full Text)

{0} page 1 of 2 K964370 GE Medical Systems JAN 10 1997 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, November 1, 1996 - **Identification of the Product** Signa Contour 2 Magnetic Resonance System Manufactured by: GE Yokogawa Medical Systems, Ltd. 4-7-127, Asahigaoka, Hino-shi Tokyo, 191 Japan - **Marketed Devices** The Signa Contour 2 MR System with new 0.5T magnet is substantially equivalent to the currently marketed Signa Contour System (software and electronics). - **Device Description** The Signa Contour 2 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 Contour 2 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 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 Contour 2 System are 45 Kg lighter and has a zero cryogen boil off rate as compared to 0.075 liters per hour for the Signa Contour System. - **Summary of Studies** The Signa Contour 2 System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. The Signa Contour 2 System is comparable to the Signa Contour MR System. - **Conclusions** It is the opinion of GE that the Signa Contour 2 System is substantially equivalent to the Signa Contour MR Systems. The Signa Contour 2 does not include any new indications for use, nor does use of this device result in any new potential hazards.