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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 K123970
Device Name CAAS INTRAVASCULAR
Applicant
Pie Medical Imaging BV
Becanusstraat 13 D
Maastricht,  NL 6216 BX
Applicant Contact Florie Daniels
Correspondent
Pie Medical Imaging BV
Becanusstraat 13 D
Maastricht,  NL 6216 BX
Correspondent Contact Florie Daniels
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/26/2012
Decision Date 02/06/2013
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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