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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K050703
Device Name QBRAIN
Applicant
Medis Medical Imaging Systems BV
Schuttersveld 9
Leiden,  NL 2316XG
Applicant Contact J.I. HOLLANDER
Correspondent
Medis Medical Imaging Systems BV
Schuttersveld 9
Leiden,  NL 2316XG
Correspondent Contact J.I. HOLLANDER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/18/2005
Decision Date 04/21/2005
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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