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510(k) K254001

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) by Spectrum Dynamics Medical, Ltd. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2026
Date Received
December 15, 2025
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 Spectrum Dynamics Medical, Ltd.

  • K253532 — TruSPECT Processing Station (December 30, 2025)
  • K230600 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (April 28, 2023)
  • K212230 — TruSPECT Radiological Image Processing Station (August 16, 2021)
  • K190457 — VERITON CT whole body SPECT/CT system (July 12, 2019)
  • K182484 — VERITON CT whole body SPECT/CT system (November 9, 2018)
  • K180514 — VERITON NM (April 25, 2018)
  • K161740 — D-SPECT Scanner, D-SPECT L Scanner (November 4, 2016)

Other clearances for product code KPS

  • K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 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)
  • K251153 — Aurora (June 12, 2025)