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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 K162483
Device Name Symbia Intevo Bold
Applicant
SIEMENS MEDICAL SOLUTIONS, USA, INC.
2501 N. BARRINGTON ROAD
Hoffman Estates,  IL  60192 -2061
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 Received09/06/2016
Decision Date 01/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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