Cleared Traditional

K994283 - MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM

K994283 is an FDA 510(k) clearance for MRI- MAGNETIC RESONANCE ANALYTICAL SOFT..., manufactured by Medis Medical Imaging Systems BV. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K994283 · Medis Medical Imaging Systems BV · Radiology device
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Aug 2000
Decision
254d
Days
Class 2
Risk

K994283 is an FDA 510(k) clearance for the MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medis Medical Imaging Systems BV (Leiden, NL). The FDA issued a Cleared decision on August 30, 2000 after a review of 254 days - an extended review 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: 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 Medis Medical Imaging Systems BV devices

FDA 510(k) Submission Details - K994283

510(k) Number K994283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1999
Decision Date August 30, 2000
Days to Decision 254 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
147d slower than avg
Panel avg: 107d · This submission: 254d
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 956
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K994283.
MAGNETOM ALLEGRA SYSTEM
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K001796 · Philips Medical Systems North America, Inc. · Sep 2000
EXPLORER GRADIENT
K001987 · Philips Medical Systems North America, Inc. · Sep 2000
POWERDRIVE 350 OPTION
K002415 · Philips Medical Systems (Cleveland), Inc. · Aug 2000
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
K002225 · Siemens Medical Solutions USA, Inc. · Aug 2000
HITACHI AIRIS II
K001334 · Hitachi Medical Systems America, Inc. · Jul 2000