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510(k) K242124

Sim&Size by Sim&Cure — Product Code PZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2024
Date Received
July 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class
Class II
Regulation Number
892.2050
Review Panel
CV
Submission Type

Visualization and measurement of blood vessels and intravascular devices for preoperational planning.

Other clearances by Sim&Cure

  • K253122 — Sim&Size (December 23, 2025)
  • K222664 — Sim&Size (January 27, 2023)
  • K212373 — Sim&Size (January 27, 2022)
  • K202322 — Sim&Size (December 31, 2020)
  • K190049 — Sim&Size (September 17, 2019)

Other clearances for product code PZO

  • K253122 — Sim&Size (December 23, 2025)
  • K250160 — ANKYRAS (May 6, 2025)
  • K230006 — Ankyras (December 28, 2023)
  • K222664 — Sim&Size (January 27, 2023)
  • K213838 — AneuGuide (June 1, 2022)
  • K212373 — Sim&Size (January 27, 2022)
  • K202322 — Sim&Size (December 31, 2020)
  • K190049 — Sim&Size (September 17, 2019)
  • K171534 — SurgicalPreview (November 8, 2017)