Home / 510(k) Clearances / K181813

510(k) K181813

ImmersiveView Surgical Plan (IVSP®) by Immersivetouch — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2020
Date Received
July 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Wire, And Bone Drill, Manual
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Immersivetouch

  • K230249 — Ikshana (October 16, 2023)
  • K210726 — ImmersiveTouch (September 29, 2021)
  • K140860 — ImmersiveTouch3 and MicrovisTouch (December 16, 2014)

Other clearances for product code DZJ

  • K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (February 21, 2025)
  • K242263 — TECHFIT DISRP® System (December 11, 2024)
  • K231520 — tmCMF Solution (October 2, 2023)
  • K230276 — TECHFIT DISRP® System (June 23, 2023)
  • K223024 — MedCAD AccuPlan System (March 7, 2023)
  • K220366 — EmbedMed (September 30, 2022)
  • K220648 — OMF ASP System (August 11, 2022)
  • K212570 — OsteoPlan System (February 11, 2022)
  • K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (June 28, 2021)
  • K193301 — coDiagnostiX (June 21, 2021)