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510(k) K231833

Biograph Vision.X and Biograph Vision.X Edge by Siemens Medical Solutions USA, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2023
Date Received
June 22, 2023
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

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  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K250170 — PHAROS (August 15, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
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