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Vital Images, Inc.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0169-2014Class IIVitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (October 21, 2013
Z-1181-2013Class IIVitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fMarch 15, 2013
Z-1144-2013Class IIVitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea EnterpMarch 15, 2013
Z-1002-2013Class IIVitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to veFebruary 5, 2013
Z-0186-2013Class IISoftware for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model August 13, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K181247Vitrea CT Brain PerfusionNovember 20, 2018
K182230Multi Modality ViewerSeptember 7, 2018
K172855Vitrea Advanced Visualization, Version 7.6October 5, 2017
K163232Vitrea ViewJuly 21, 2017
K163574Multi Modality ViewerJanuary 26, 2017
K161157Vitrea CT Dual Energy Image ViewNovember 3, 2016
K161419Multi Modality ViewerJuly 13, 2016
K160150Vitrea CT Colon AnalysisMarch 16, 2016
K151283Lung Analysis SoftwareOctober 30, 2015
K151919Vitrea CT Lung Density Analysis SoftwareOctober 10, 2015
K151115MR Core SoftwareJune 3, 2015
K150104Vitrea CT Myocardial PerfusionApril 17, 2015
K150738VitreaViewApril 6, 2015
K150258Vitrea, Version 7.0 Medical Image Processing SoftwareMarch 5, 2015
K143079Endovascular Stent Planning SoftwareDecember 4, 2014
K141302VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)August 1, 2014
K140395VITREA IMAGE DENOISING SOFTWAREMay 13, 2014
K122578VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNINGFebruary 25, 2013
K121213VITREAADVANCEDNovember 2, 2012
K122136VITREAVIEWSeptember 7, 2012