The new In-Room MRC is intended to facilitate conventional procedures. The new operating console allows the system operator to control and monitor main system functions inside the RF-cabin.

Device Description

The In-Room MRC consists of a local monitor and mouse. The local monitor is a liquid crystal display (LCD) with the same image resolution as the standard diagnostic console. The scan-room-mouse is positioned alongside the magnet and controls the functions of the local monitor. It is similar to the conventional track ball-mouse used at the standard MR console and is fully compatible with the software.

AI/ML Overview

This device is a Magnetic Resonance Diagnostic Device. It does not appear to use AI. The acceptance criteria and study information is not applicable for this device.

Summary

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ﺮ ﺍﻟﻤﺮﺍﺟﻊ

K962927

SEP 2 5 1996

Appendix 8:

510(k) Summary

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I. General Information.
Establishment:
• Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, N.J. 08830
Registration Number:	2240869
Contact Person:	Cathy Anne PintoSr. Technical Specialist, Regulatory Affairs(908) 321-4887(908) 321-4841
Date of Summary Preparation:	July 26, 1996
Device Name:
• Trade Name:	In-Room MRC/MAGNETOM VISION and IMPACT
• Classification Name:	Magnetic Resonance Diagnostic Device,CFR § 892.1000
• Classification:	Class II
• Performance Standards:	None established under Section 514 ofthe Food, Drug, and Cosmetic Act.

II. Safety and Effectiveness Information Supporting Substantial Equivalence.

Device Description:

Intended Use:

The new In-Room MRC is intended to facilitate conventional procedures. The new operating console allows the system operator to control and monitor main system functions inside the RF-cabin.

07/26/96

510(k)

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SIEMENS

Technological Characteristics:

The local monitor and mouse serve the same function as the standard MR console except that, patient registration must be performed from the standard MR console in the control room via the keyboard.

General Safety and Effectiveness Concerns:

Operation of the new In-Room MRC does not affect any of the MR safety and performance parameters, including:

[safety]

static field strength, -
RF exposure, -
time varying magnetic fields -
acoustic noise levels -

[performance]

signal-to-noise, -
high contrast spatial resolution,
slice thickness,
image uniformity and,
geometric distortion.

In addition, all new components have been designed and tested for MR compatibility with the system. There is no electrodynamical interference with the static magnetic field, the magnetic field gradients, or the rf system. Consequently, there is no influence on image quality or system performance.

Substantial Equivalence:

The In-Room MRC for the VISION and the IMPACT is substantially equivalent to In-Room MRC commercially available for the MAGNETOM OPEN system.

Kathleen Rutherford

Kathleen M. Rutherford Manager, Regulatory Submissions Imaging Systems Group Siemens Medical Systems, Inc.

7/26/96
Date

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.