510(k) K261315

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family by Siemens Medical Solutions USA, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2026
Date Received
April 21, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type