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510(k) K223152

Vision 2, EVARVision, TrackVision 2, HeartVision 2 by GE Medical Systems SCS — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2022
Date Received
October 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • 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)

Other clearances for product code LLZ

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)