Company ยท US
Vital Images, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2018. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 20, 2018 | K181247 | Vitrea CT Brain Perfusion Vital Images, Inc. | LLZ |
| Sep 7, 2018 | K182230 | Multi Modality Viewer Vital Images, Inc. | LLZ |
| Oct 5, 2017 | K172855 | Vitrea Advanced Visualization, Version 7.6 Vital Images, Inc. | LLZ |
| Jul 21, 2017 | K163232 | Vitrea View Vital Images, Inc. | LLZ |
| Jan 26, 2017 | K163574 | Multi Modality Viewer Vital Images, Inc. | LLZ |
| Nov 3, 2016 | K161157 | Vitrea CT Dual Energy Image View Vital Images, Inc. | JAK |
| Jul 13, 2016 | K161419 | Multi Modality Viewer Vital Images, Inc. | LLZ |
| Mar 16, 2016 | K160150 | Vitrea CT Colon Analysis Vital Images, Inc. | LLZ |
| Oct 30, 2015 | K151283 | Lung Analysis Software Vital Images, Inc. | JAK |
| Oct 10, 2015 | K151919 | Vitrea CT Lung Density Analysis Software Vital Images, Inc. | JAK |
| Jun 3, 2015 | K151115 | MR Core Software Vital Images, Inc. | LLZ |
| Apr 17, 2015 | K150104 | Vitrea CT Myocardial Perfusion Vital Images, Inc. | JAK |
| Apr 6, 2015 | K150738 | VitreaView Vital Images, Inc. | LLZ |
| Mar 5, 2015 | K150258 | Vitrea, Version 7.0 Medical Image Processing Software Vital Images, Inc. | LLZ |
| Dec 4, 2014 | K143079 | Endovascular Stent Planning Software Vital Images, Inc. | LLZ |
| Aug 1, 2014 | K141302 | VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) Vital Images, Inc. | LLZ |
| May 13, 2014 | K140395 | VITREA IMAGE DENOISING SOFTWARE Vital Images, Inc. | LLZ |
| Feb 25, 2013 | K122578 | VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING Vital Images, Inc. | LLZ |
| Nov 2, 2012 | K121213 | VITREAADVANCED Vital Images, Inc. | LLZ |
| Sep 7, 2012 | K122136 | VITREAVIEW Vital Images, Inc. | LLZ |
| Nov 18, 2011 | K112531 | VITREA CT MYOCARDIAL ANALYSIS Vital Images, Inc. | LLZ |
| Jul 28, 2011 | K111892 | VITREAVIEW SOFTWARE 6.1 Vital Images, Inc. | LLZ |
| Jun 5, 2009 | K091498 | VITREA ENDOVASCULAR STENT PLANNING SOFTWARE Vital Images, Inc. | LLZ |
| Feb 20, 2008 | K072821 | VITREA 4DCT Vital Images, Inc. | LLZ |
| May 30, 2007 | K071362 | VITAL CONNECT 4.1 Vital Images, Inc. | LLZ |
| May 25, 2007 | K071331 | VITREA VERSION 4.0 Vital Images, Inc. | LLZ |
| Aug 21, 2006 | K062328 | VITREAACCESS, VERSION 1.0 Vital Images, Inc. | LLZ |
| Aug 10, 2006 | K062154 | VITAL CONNECT 4.0 Vital Images, Inc. | LLZ |
| Jun 27, 2006 | K061624 | VITREA, VERSION 3.9 Vital Images, Inc. | LLZ |
| Mar 9, 2006 | K060378 | VITREA2 VERSION 3.8.1 Vital Images, Inc. | LLZ |
| Dec 15, 2005 | K052632 | VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE Vital Images, Inc. | LLZ |
| Dec 15, 2004 | K043333 | VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM Vital Images, Inc. | LLZ |
| Apr 19, 2004 | K040876 | ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE Vital Images, Inc. | LLZ |
| Feb 24, 2004 | K040305 | VITREA2 VERSION 3.5 Vital Images, Inc. | LLZ |
| Oct 29, 2003 | K032748 | VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE Vital Images, Inc. | LLZ |
| Jan 23, 2001 | K003639 | VITREA 2 CT PERFUSION OPTION Vital Images, Inc. | JAK |
| Dec 27, 2000 | K003230 | V SCORE WITH AUTO GATE MODEL TBD Vital Images, Inc. | JAK |
| Oct 19, 2000 | K002519 | VITREA 2, VERSION 2.1 Vital Images, Inc. | LLZ |
| Jun 30, 2000 | K001682 | VSCORE WITH EKG SIGNAL GATING Vital Images, Inc. | JAK |
| May 11, 1999 | K990442 | ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 Vital Images, Inc. | LLZ |
| Nov 24, 1995 | K953259 | VOXELVIEW Vital Images, Inc. | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2013 | Vital Images, Inc. VitreaCore software. Versions subject to the limitation:
6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as
well as their upgrades, and 6.5.
The VitreaCore (ViTALConnect) system is Terminated |
LLZ | K062154 K071362 |
| Apr 26, 2013 | Vital Images, Inc. Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite.
Noninvasive post-processing application designed to e Terminated |
LLZ | K032748 K121213 |
| Apr 18, 2013 | Vital Images, Inc. Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdv Terminated |
LLZ | K043333 K052632 |
| Mar 27, 2013 | Vital Images, Inc. Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3
The software is a medical diagnostic system that allows t Terminated |
LLZ | K002519 K062154 |
| Nov 1, 2012 | Vital Images, Inc. Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES):
VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2
VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6 Terminated |
LLZ | K032748 K052632 |
| Jan 11, 2012 | Vital Images, Inc. Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1.
A medica Terminated |
LLZ | K061624 K071331 |
| Feb 2, 2011 | Vital Images, Inc. Vital Connect 4.0 & 4.1, radiological image processing software
A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired fro Terminated |
LLZ | K062154 K071362 |
| Dec 21, 2010 | Vital Images, Inc. Vital, Vitrea fX and Vitrea Enterprise Suite fX
Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1
Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3
The Vitrea 4D CT Brain Perfusion option is intende Terminated |
LLZ | K072821 |
| May 13, 2010 | Vital Images, Inc. Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Terminated |
LLZ | K091498 |
| Jan 31, 2008 | Vital Images, Inc. Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allow Terminated |
LLZ | K062154 K071362 |