Cleared Traditional

MRI EQUIPMENT COVER (K993682) - FDA 510(k) Clearance

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

K993682 · Image-Guided Neurologics, Inc. · Radiology device
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Jan 2000
Decision
80d
Days
Class 2
Risk

K993682 is an FDA 510(k) clearance for the MRI EQUIPMENT COVER. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Image-Guided Neurologics, Inc. (Melbourne, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 80 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 Image-Guided Neurologics, Inc. devices

Submission Details

510(k) Number K993682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date January 20, 2000
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K993682.
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