Cleared Traditional

K994351 - M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM

K994351 is an FDA 510(k) clearance for M.R. VISION 2000 ULTRA AUDIO VISUAL SYS..., manufactured by Resonance Technology, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K994351

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
Combination Product No
PCCP Authorized No
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.

LNH Device Classification - Class 2, Special Controls

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 912
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K994351.
SPIRAL IMAGING OPTION
K000802 · GE Medical Systems · May 2000
STEROTACTIC LOCALIZATION DEVICE (SLD)
K000832 · Philips Medical Systems North America, Inc. · Apr 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
K000315 · GE Medical Systems · Mar 2000
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
K994287 · Fonar Corp. · Mar 2000
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
K994282 · Medis Medical Imaging Systems BV · Mar 2000
EXCELART WITH PIANISSIMO
K993803 · Toshiba America Mri, Inc. · Feb 2000