AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM

• K Number: K955811
• Device Name: AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 1996-03-29 ( 94 days)
• Product Code: LNH
• Regulation Number: 892.1000
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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.

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.