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510(k) K233677

Biograph VK10 by Siemens Medical Solutions USA, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2024
Date Received
November 16, 2023
Clearance Type
Traditional
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

Other clearances by Siemens Medical Solutions USA, Inc.

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  • K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultras (November 17, 2025)
  • K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ul (November 13, 2025)
  • K250241 — Cios Select (November 4, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K251481 — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ul (August 20, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251523 — Cios Spin (July 29, 2025)
  • K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (July 28, 2025)

Other clearances for product code KPS

  • K260524 — uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panviv (April 3, 2026)
  • K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 13, 2026)
  • K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
  • K253844 — AnyScan 3.0 NM Scanner Family (December 30, 2025)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • K251401 — PennPET Explorer Positron Emission Tomograph (November 25, 2025)
  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K250170 — PHAROS (August 15, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)