Cleared Traditional

K994282 - MRI- FLOW ANALYTICAL SOFTWARE PACKAGE

K994282 is the FDA 510(k) clearance for MRI- FLOW ANALYTICAL SOFTWARE PACKAGE by Medis Medical Imaging Systems BV. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K994282 · Medis Medical Imaging Systems BV · Radiology device
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Mar 2000
Decision
73d
Days
Class 2
Risk

K994282 is an FDA 510(k) clearance for the MRI- FLOW ANALYTICAL SOFTWARE PACKAGE. 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 March 2, 2000 after a review of 73 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 Medis Medical Imaging Systems BV devices

Submission Details

510(k) Number K994282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1999
Decision Date March 02, 2000
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
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 813
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K994282.
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
EXCELART WITH PIANISSIMO
K993803 · Toshiba America Mri, Inc. · Feb 2000
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
K993574 · Toshiba America Mri, Inc. · Jan 2000
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K993731 · Siemens Medical Solutions USA, Inc. · Dec 1999