The auxiliary patient table is designed to further accommodate large patients, trauma patients, claustrophobic patients, and those patients requiring monitoring. The new auxiliary table is designed to support up to 200kg (440 lbs) and is compatible with the commercially available CP Head and Multi-purpose Coils. This new system option is not intended as a transportation trolley.

Device Description

The auxiliary patient table docks into the standard OPEN table area and increases the vertical gap (ie. patient gap) of the magnet. The auxiliary patient table consists of a base frame, an extension frame, and a table plate.

AI/ML Overview

This Siemens 510(k) summary (K955811) describes an auxiliary patient table for the MAGNETOM OPEN MRI system. It does not contain information about a study with acceptance criteria and device performance as it's a submission for a device modification, not a new AI/software-based medical device.

Therefore, I cannot provide the requested table or response for points 2-9 based on the provided text. The document focuses on showing that the auxiliary patient table does not change the fundamental safety and performance of the existing MRI system.

Summary

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SIEMENS

General Information.

K955811

510 (k) Summary

MAR 2 9 1996

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.

. 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 (908) 321-4887 (908) 321-4841 December 22, 1995 ● Date of Summary Preparation: Proprietary Trade Name: . Auxiliary Patient Table/ MAGNETOM OPEN . Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000 . Classification: Class II None established under Section . Performance Standards: 514 of the Food, Drug, and Cosmetic Act.

II. Safety and Effectiveness Information Supporting Substantial Equivalence.

· Device Description:

Siemens Medical Systems, Inc.

maging Systems Group

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SIEMENS

· Intended Use

· Technological Characteristics

There is no change to the magnet, rf system, and gradient system of the MAGNETOM OPEN by introduction of the auxiliary patient table.

• General Safety and Effectiveness Concerns:

Operation of the MAGNETOM OPEN system with the new auxiliary patient table is substantially equivalent to standard operation of the MAGNETOM OPEN system. The following safety parameter action levels:

static field strength,
-RF exposure,

and performance levels:

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

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.

• Substantial Equivalence:

The MAGNETOM OPEN with the new auxiliary patient table is substantially equivalent to standard operation of the MAGNETOM OPEN system.

Kathleen Rutherford

Kathleen M. Rutherfor Manager, Regulatory Submissions

12/22/95
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.