Cleared Traditional

K955811 - AUXILIARY PATIENT TABLE/MAGNETOM OPEN S...

K955811 is the FDA 510(k) clearance for AUXILIARY PATIENT TABLE/MAGNETOM OPEN S... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K955811 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
94d
Days
Class 2
Risk

K955811 is an FDA 510(k) clearance for the AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 29, 1996 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K955811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 29, 1996
Days to Decision 94 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K955811.
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
K960294 · Philips Medical Systems (Cleveland), Inc. · Apr 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954353 · General Electric Co. · Apr 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954354 · General Electric Co. · Apr 1996
VERSION 3.7 OPERATING SYSTEM SOFTWARE
K960181 · Hitachi Medical Systems America, Inc. · Mar 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
K954646 · Philips Medical Systems (Cleveland), Inc. · Jan 1996
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
K945945 · Philips Medical Systems North America, Inc. · Dec 1995