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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K023970
Device Name QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
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 Number892.1600
Classification Product Code
IZI  
Date Received11/29/2002
Decision Date 01/24/2003
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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