VITREA2, Version 3.4 Medical Image Processing Software

• • Terminated Z-1181-2013 FDA Class II ·initiated 15 Mar 2013

  Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.

• • Terminated Z-0186-2013 FDA Class II ·initiated 13 Aug 2012

  Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.

510(k) Number

K032748 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Multi Modality Viewer

  Class II

  FDA 510(k) K182230 Active Cleared 7 Sep 2018

• Vitrea View

  Class II

  FDA 510(k) K163232 Active Cleared 21 Jul 2017

• Vitrea Version 4.0

  Class II

  FDA 510(k) K071331 Active Cleared 25 May 2007

• Vitrea CT Dual Energy Image View

  Class II

  FDA 510(k) K161157 Active Cleared 3 Nov 2016

• VITREA2, Version 3.7 Medical Image Processing System

  Class II

  FDA 510(k) K043333 Active Cleared 15 Dec 2004

• Vitrea, Version 3.9

  Class II

  FDA 510(k) K061624 Active Cleared 27 Jun 2006

See all devices from Vital Images, Inc. →