Home / 510(k) Clearances / K122578

510(k) K122578

VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING by Vital Images, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2013
Date Received
August 23, 2012
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

Other clearances by Vital Images, Inc.

  • K181247 — Vitrea CT Brain Perfusion (November 20, 2018)
  • K182230 — Multi Modality Viewer (September 7, 2018)
  • K172855 — Vitrea Advanced Visualization, Version 7.6 (October 5, 2017)
  • K163232 — Vitrea View (July 21, 2017)
  • K163574 — Multi Modality Viewer (January 26, 2017)
  • K161157 — Vitrea CT Dual Energy Image View (November 3, 2016)
  • K161419 — Multi Modality Viewer (July 13, 2016)
  • K160150 — Vitrea CT Colon Analysis (March 16, 2016)
  • K151283 — Lung Analysis Software (October 30, 2015)
  • K151919 — Vitrea CT Lung Density Analysis Software (October 10, 2015)

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)