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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 K173578
Device Name Biograph mCT Family of PET/CT Systems
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Tabitha Estes
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Tabitha Estes
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received11/20/2017
Decision Date 12/20/2017
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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