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510(k) K241898

Symbia SPECT and SPECT/CT Systems by Siemens Healthineers — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2024
Date Received
June 28, 2024
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

Other clearances by Siemens Healthineers

  • K253023 — BIOGRAPH One (January 15, 2026)
  • K253495 — syngo.MR Applications (VB80) (November 20, 2025)
  • K251059 — Syngo Carbon Clinicals (VA41) (October 24, 2025)
  • K183575 — ACUSON S3000, S2000 Diagnostic Ultrasound System (March 20, 2019)

Other clearances for product code KPS

  • 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)
  • K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (July 3, 2025)