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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K994283
Device Name MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
Applicant
Medis Medical Imaging Systems BV
Poortgebouw Rijnsburgerweg 10
Leiden,  NL 2333 AA
Applicant Contact J.I. HOLLANDER
Correspondent
Medis Medical Imaging Systems BV
Poortgebouw Rijnsburgerweg 10
Leiden,  NL 2333 AA
Correspondent Contact J.I. HOLLANDER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/20/1999
Decision Date 08/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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