Cleared Traditional

K994117 - MR ENHANCER

K994117 is an FDA 510(k) clearance for MR ENHANCER, manufactured by I.Z.I. Corp.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K994117 · I.Z.I. Corp. · Radiology device
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Feb 2000
Decision
60d
Days
Class 2
Risk

K994117 is an FDA 510(k) clearance for the MR ENHANCER. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by I.Z.I. Corp. (Crofton, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.Z.I. Corp. devices

FDA 510(k) Submission Details - K994117

510(k) Number K994117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date February 04, 2000
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
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 K994117.
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
MRI EQUIPMENT COVER
K993682 · Image-Guided Neurologics, Inc. · Jan 2000
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
K993574 · Toshiba America Mri, Inc. · Jan 2000
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
K994316 · Siemens Medical Corp. · Jan 2000