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510(k) K181247

Vitrea CT Brain Perfusion by Vital Images, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2018
Date Received
May 10, 2018
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.

  • 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)
  • K151115 — MR Core Software (June 3, 2015)

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  • 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)