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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K162337
Device Name Symbia 6.5
Applicant
SIEMENS MEDICAL SOLUTIONS, USA, INC
2501 N. BARRINGTON ROAD
Hoffman Estates,  IL  60192
Applicant Contact Cynthia Busch
Correspondent
SIEMENS MEDICAL SOLUTIONS, USA, INC
2501 N. BARRINGTON ROAD
Hoffman Estates,  IL  60192 -2061
Correspondent Contact Cynthia Busch
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received08/22/2016
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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