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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 K261315
Device Name Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Applicant Contact Tabitha Estes
Correspondent
Siemens Medical Solution USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Correspondent Contact Tabitha Estes
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received04/21/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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