FDA 510(k) Applications Submitted by VITAL IMAGES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160150 |
01/21/2016 |
Vitrea CT Colon Analysis |
Vital Images, Inc. |
| K161157 |
04/25/2016 |
Vitrea CT Dual Energy Image View |
VITAL IMAGES, INC. |
| K121213 |
04/20/2012 |
VITREAADVANCED |
VITAL IMAGES, INC. |
| K112531 |
08/31/2011 |
VITREA CT MYOCARDIAL ANALYSIS |
VITAL IMAGES, INC. |
| K091498 |
05/20/2009 |
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE |
VITAL IMAGES, INC. |
| K182230 |
08/17/2018 |
Multi Modality Viewer |
Vital Images, Inc. |
| K111892 |
07/05/2011 |
VITREAVIEW SOFTWARE 6.1 |
VITAL IMAGES, INC. |
| K122136 |
07/18/2012 |
VITREAVIEW |
VITAL IMAGES, INC. |
| K122578 |
08/23/2012 |
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING |
VITAL IMAGES, INC. |
| K161419 |
05/23/2016 |
Multi Modality Viewer |
VITAL IMAGES, INC. |
| K151919 |
07/13/2015 |
Vitrea CT Lung Density Analysis Software |
VITAL IMAGES, INC. |
| K172855 |
09/20/2017 |
Vitrea Advanced Visualization, Version 7.6 |
Vital Images, Inc. |
| K140395 |
02/18/2014 |
VITREA IMAGE DENOISING SOFTWARE |
VITAL IMAGES, INC. |
| K151283 |
05/14/2015 |
Lung Analysis Software |
Vital Images, Inc. |
| K141302 |
05/19/2014 |
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) |
VITAL IMAGES, INC. |
| K143079 |
10/27/2014 |
Endovascular Stent Planning Software |
VITAL IMAGES, INC. |
| K990442 |
02/10/1999 |
ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 |
VITAL IMAGES, INC. |
| K001682 |
06/01/2000 |
VSCORE WITH EKG SIGNAL GATING |
VITAL IMAGES, INC. |
| K002519 |
08/15/2000 |
VITREA 2, VERSION 2.1 |
VITAL IMAGES, INC. |
| K003230 |
10/16/2000 |
V SCORE WITH AUTO GATE MODEL TBD |
VITAL IMAGES, INC. |
| K003639 |
11/24/2000 |
VITREA 2 CT PERFUSION OPTION |
VITAL IMAGES, INC. |
| K032748 |
09/05/2003 |
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE |
VITAL IMAGES, INC. |
| K181247 |
05/10/2018 |
Vitrea CT Brain Perfusion |
Vital Images, Inc. |
| K163574 |
12/19/2016 |
Multi Modality Viewer |
Vital Images, Inc. |
| K040305 |
02/09/2004 |
VITREA2 VERSION 3.5 |
VITAL IMAGES, INC. |
| K060378 |
02/14/2006 |
VITREA2 VERSION 3.8.1 |
VITAL IMAGES, INC. |
| K040876 |
04/05/2004 |
ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE |
VITAL IMAGES, INC. |
| K071331 |
05/11/2007 |
VITREA VERSION 4.0 |
VITAL IMAGES, INC. |
| K061624 |
06/12/2006 |
VITREA, VERSION 3.9 |
VITAL IMAGES, INC. |
| K062154 |
07/28/2006 |
VITAL CONNECT 4.0 |
VITAL IMAGES, INC. |
| K062328 |
08/10/2006 |
VITREAACCESS, VERSION 1.0 |
VITAL IMAGES, INC. |
| K052632 |
09/26/2005 |
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE |
VITAL IMAGES, INC. |
| K072821 |
10/02/2007 |
VITREA 4DCT |
VITAL IMAGES, INC. |
| K043333 |
12/03/2004 |
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM |
VITAL IMAGES, INC. |
| K071362 |
05/15/2007 |
VITAL CONNECT 4.1 |
VITAL IMAGES, INC. |
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