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510(k) K141302

VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) by Vital Images, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2014
Date Received
May 19, 2014
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)

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