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510(k) K243672

CardIQ Suite by GE Medical Systems SCS — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
November 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by GE Medical Systems SCS

  • K251199 — Allia Moveo (December 9, 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)
  • K222895 — DynamicIQ (November 22, 2022)
  • K223152 — Vision 2, EVARVision, TrackVision 2, HeartVision 2 (November 22, 2022)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)