IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS

K962927 · Siemens Medical Solutions USA, Inc. · LNH · Sep 25, 1996 · Radiology

Device Facts

• Record ID: K962927
• Device Name: IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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.

Device Story

In-Room MRC consists of an LCD monitor and scan-room-mouse; provides remote interface for MAGNETOM VISION and IMPACT MR systems. Operated by system technician inside RF-cabin; allows control/monitoring of main system functions during imaging procedures. Input via mouse; output via LCD display. Mirroring functionality of standard diagnostic console; patient registration remains restricted to control room console. Device facilitates workflow by enabling operator presence near magnet; no impact on MR safety parameters (static field, RF exposure, gradients, acoustic noise) or performance metrics (SNR, resolution, distortion).

Clinical Evidence

Bench testing only. Device evaluated for MR compatibility; confirmed no electrodynamical interference with static magnetic field, gradients, or RF system. No impact on image quality or system performance parameters (SNR, spatial resolution, slice thickness, uniformity, geometric distortion).

Technological Characteristics

Components: LCD monitor, scan-room-mouse. Connectivity: Wired interface to MAGNETOM VISION/IMPACT MR systems. MR compatibility: Designed to operate within RF-cabin without interference to static magnetic field, gradients, or RF system. Software: Compatible with existing system software.

Indications for Use

Indicated for use by system operators to control and monitor main magnetic resonance imaging system functions from within the RF-cabin during conventional procedures.

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

• MAGNETOM OPEN In-Room MRC

Submission Summary (Full Text)

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Appendix 8: 510(k) Summary

K962937

SEP 25 1996

Appendix 8:
510(k) Summary

MAGNETOM VISION, IMPACT 510(k) 07/26/96 Appendix 8
In-Room MRC

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# SIEMENS

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 South
Iselin, N.J. 08830

**Registration Number:** 2240869

### Contact Person:

Cathy Anne Pinto
Sr. Technical Specialist, Regulatory Affairs
[phone]
[phone]

**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 of the Food, Drug, and Cosmetic Act.

## II. Safety and Effectiveness Information Supporting Substantial Equivalence.

### 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.

### 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.

MAGNETOM VISION, IMPACT 510(k) 07/26/96 Page 1
Siemens Medical Systems, Inc.
186 Wood Ave. South
Iselin, NJ 08830
Tel: [phone]
Fax: [phone]

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

7/26/96
Date

MAGNETOM VISION, IMPACT 510(k) 07/26/96 Page 2
In-Room MRC