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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 K041682
Device Name CAAS MRV
Applicant
Pie Medical Imaging BV
Becanusstraat 13 D
Maastricht,  NL 6216 BX
Applicant Contact CARLA DE VRIES
Correspondent
Pie Medical Imaging BV
Becanusstraat 13 D
Maastricht,  NL 6216 BX
Correspondent Contact CARLA DE VRIES
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/21/2004
Decision Date 07/27/2004
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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