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510(k) K222895

DynamicIQ by GE Medical Systems SCS — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2022
Date Received
September 23, 2022
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 GE Medical Systems SCS

  • K251199 — Allia Moveo (December 9, 2025)
  • K243672 — CardIQ Suite (June 18, 2025)
  • K243651 — VersaViewer (April 21, 2025)
  • K243446 — 3DXR (February 25, 2025)
  • K233731 — CardIQ Suite (August 1, 2024)
  • K233714 — BreView (January 25, 2024)
  • K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR (October 11, 2023)
  • K223424 — Spine Auto Views (July 13, 2023)
  • K223490 — FlightPlan for Embolization (March 21, 2023)
  • K223152 — Vision 2, EVARVision, TrackVision 2, HeartVision 2 (November 22, 2022)

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)