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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 K011582
Device Name QCU ANALYTICAL SOFTWARE PACKAGE
Applicant
Medis Medical Imaging Systems BV
Poortgebouw Rijnsburgerweg 10
Leiden,  NL 2333 AA
Applicant Contact J.J. HOLLANDER
Correspondent
Medis Medical Imaging Systems BV
Poortgebouw Rijnsburgerweg 10
Leiden,  NL 2333 AA
Correspondent Contact J.J. HOLLANDER
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
IYO  
Date Received05/23/2001
Decision Date 07/31/2001
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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