Cleared Traditional

M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM (K994351) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994351 · Resonance Technology, Inc. · Radiology device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994351 is an FDA 510(k) clearance for the M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Resonance Technology, Inc. (Northridge, US). The FDA issued a Cleared decision on March 22, 2000 after a review of 90 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 Resonance Technology, Inc. devices

Submission Details

510(k) Number K994351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date March 22, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K994351.
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
K002225 · Siemens Medical Solutions USA, Inc. · Aug 2000
SPIRAL IMAGING OPTION
K000802 · GE Medical Systems · May 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
K000315 · GE Medical Systems · Mar 2000
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K993731 · Siemens Medical Solutions USA, Inc. · Dec 1999
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
K990826 · Siemens Medical Solutions USA, Inc. · Nov 1999
QUANTITATIVE FLOW
K992225 · Philips Medical Systems (Cleveland), Inc. · Sep 1999