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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 K193178
Device Name Biograph Horizon
Applicant
Siemens Medical Solution USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Alaine Medio
Correspondent
Siemens Medical Solution USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Alaine Medio
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received11/18/2019
Decision Date 02/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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