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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 K241898
Device Name Symbia SPECT and SPECT/CT Systems
Applicant
Siemens Healthineers
810 Innovation Dr.
Knoxville,  TN  37938
Applicant Contact Tabitha Estes
Correspondent
Siemens Healthineers
810 Innovation Dr.
Knoxville,  TN  37938
Correspondent Contact Tabitha Estes
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received06/28/2024
Decision Date 07/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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