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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 K151780
Device Name CAAS Workstation
Applicant
Pie Medical Imaging BV
Philipsweg 1
Maastricht,  NL 6227 AJ
Applicant Contact FLORIE DANIELS
Correspondent
Pie Medical Imaging BV
Philipsweg 1
Maastricht,  NL 6227 AJ
Correspondent Contact FLORIE DANIELS
Regulation Number892.1600
Classification Product Code
IZI  
Subsequent Product Code
LLZ  
Date Received07/01/2015
Decision Date 03/11/2016
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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