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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 K173023
Device Name Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates,  IL  60192
Applicant Contact Tabitha Estes
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Road
Hoffman Estates,  IL  60192
Correspondent Contact Tabitha Estes
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received09/28/2017
Decision Date 11/17/2017
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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