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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 K073156
Device Name QPLAQUE MR
Applicant
Medis Medical Imaging Systems BV
9 Schuttersveld
P.O. Box 384
Leiden,  NL 2316 XG
Applicant Contact J.I. HOLLANDER
Correspondent
Medis Medical Imaging Systems BV
9 Schuttersveld
P.O. Box 384
Leiden,  NL 2316 XG
Correspondent Contact J.I. HOLLANDER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/08/2007
Decision Date 03/04/2008
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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