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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 K143319
Device Name Syngo X-workplace SW VD10
Applicant
Siemens Medi Cal Solutions, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact Patricia D. Jones
Correspondent
Siemens Medi Cal Solutions, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact Patricia D. Jones
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/19/2014
Decision Date 02/24/2015
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
Recalls CDRH Recalls
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