← Product Code [LNH](/productcode/LNH) · K955811 # AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM (K955811) _Siemens Medical Solutions USA, Inc. · LNH · Mar 29, 1996 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K955811 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc. - **Product Code:** [LNH](/productcode/LNH.md) - **Decision Date:** Mar 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for 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 Story Auxiliary patient table for MAGNETOM OPEN MRI system; docks into standard table area to increase vertical patient gap. Composed of base frame, extension frame, and table plate. Supports patients up to 200kg. Compatible with CP Head and Multi-purpose coils. Used in clinical MRI environment by radiology staff. Does not alter magnet, RF, or gradient systems. Maintains standard MRI safety and performance parameters (static field, RF exposure, SNR, spatial resolution, slice thickness, uniformity, distortion). Facilitates imaging of patients previously difficult to accommodate. ## Clinical Evidence Bench testing only. Performance metrics (signal-to-noise, high contrast spatial resolution, slice thickness, image uniformity, geometric distortion) confirmed to be unaffected by the table modification. ## Technological Characteristics Mechanical accessory consisting of base frame, extension frame, and table plate. Increases vertical patient gap for MAGNETOM OPEN MRI. Supports 200kg load. Compatible with CP Head and Multi-purpose coils. No changes to magnet, RF, or gradient systems. ## Regulatory 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 (standard configuration) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SIEMENS K955811 # 510 (k) Summary MAR 29 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. ## I. General Information. - **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 - **Date of Summary Preparation:** December 22, 1995 - **Proprietary Trade Name:** Auxiliary Patient Table/ MAGNETOM OPEN - **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 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. Siemens Medical Systems, Inc. Imaging Systems Group 186 Wood Avenue South Iselin, NJ 08830 Tel: (908) 321-4500 Fax: (908) 494-2250 Page 1 {1} # SIEMENS - **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. - **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. ![img-0.jpeg](img-0.jpeg) 12/22/95 Page 2 --- **Source:** [https://fda-staging.innolitics.com/device/K955811](https://fda-staging.innolitics.com/device/K955811) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com