Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vital Images, Inc. · Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
186 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181247 | Vitrea CT Brain Perfusion | Vital Images, Inc. | 2018-11-20 | 194 | 0 |
| K182230 | Multi Modality Viewer | Vital Images, Inc. | 2018-09-07 | 21 | 0 |
| K172855 | Vitrea Advanced Visualization, Version 7.6 | Vital Images, Inc. | 2017-10-05 | 15 | 0 |
| K163232 | Vitrea View | Vital Images, Inc. | 2017-07-21 | 246 | 0 |
| K163574 | Multi Modality Viewer | Vital Images, Inc. | 2017-01-26 | 38 | 0 |
| K161157 | Vitrea CT Dual Energy Image View | Vital Images, Inc. | 2016-11-03 | 192 | 0 |
| K161419 | Multi Modality Viewer | Vital Images, Inc. | 2016-07-13 | 51 | 0 |
| K160150 | Vitrea CT Colon Analysis | Vital Images, Inc. | 2016-03-16 | 55 | 0 |
| K151283 | Lung Analysis Software | Vital Images, Inc. | 2015-10-30 | 169 | 0 |
| K151919 | Vitrea CT Lung Density Analysis Software | Vital Images, Inc. | 2015-10-10 | 89 | 0 |
| K151115 | MR Core Software | Vital Images, Inc. | 2015-06-03 | 37 | 0 |
| K150104 | Vitrea CT Myocardial Perfusion | Vital Images, Inc. | 2015-04-17 | 87 | 0 |
| K150738 | VitreaView | Vital Images, Inc. | 2015-04-06 | 17 | 0 |
| K150258 | Vitrea, Version 7.0 Medical Image Processing Software | Vital Images, Inc. | 2015-03-05 | 30 | 0 |
| K143079 | Endovascular Stent Planning Software | Vital Images, Inc. | 2014-12-04 | 38 | 0 |
| K141302 | VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) | Vital Images, Inc. | 2014-08-01 | 74 | 0 |
| K140395 | VITREA IMAGE DENOISING SOFTWARE | Vital Images, Inc. | 2014-05-13 | 84 | 0 |
| K122578 | VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANN | Vital Images, Inc. | 2013-02-25 | 186 | 0 |
| K121213 | VITREAADVANCED | Vital Images, Inc. | 2012-11-02 | 196 | 1 |
| K122136 | VITREAVIEW | Vital Images, Inc. | 2012-09-07 | 51 | 0 |
| K112531 | VITREA CT MYOCARDIAL ANALYSIS | Vital Images, Inc. | 2011-11-18 | 79 | 0 |
| K111892 | VITREAVIEW SOFTWARE 6.1 | Vital Images, Inc. | 2011-07-28 | 23 | 0 |
| K091498 | VITREA ENDOVASCULAR STENT PLANNING SOFTWARE | Vital Images, Inc. | 2009-06-05 | 16 | 1 |
| K072821 | VITREA 4DCT | Vital Images, Inc. | 2008-02-20 | 141 | 1 |
| K071362 | VITAL CONNECT 4.1 | Vital Images, Inc. | 2007-05-30 | 15 | 3 |
| K071331 | VITREA VERSION 4.0 | Vital Images, Inc. | 2007-05-25 | 14 | 1 |
| K062328 | VITREAACCESS, VERSION 1.0 | Vital Images, Inc. | 2006-08-21 | 11 | 0 |
| K062154 | VITAL CONNECT 4.0 | Vital Images, Inc. | 2006-08-10 | 13 | 4 |
| K061624 | VITREA, VERSION 3.9 | Vital Images, Inc. | 2006-06-27 | 15 | 1 |
| K060378 | VITREA2 VERSION 3.8.1 | Vital Images, Inc. | 2006-03-09 | 23 | 0 |
| K052632 | VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE | Vital Images, Inc. | 2005-12-15 | 80 | 2 |
| K043333 | VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM | Vital Images, Inc. | 2004-12-15 | 12 | 1 |
| K040876 | ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWA | Vital Images, Inc. | 2004-04-19 | 14 | 0 |
| K040305 | VITREA2 VERSION 3.5 | Vital Images, Inc. | 2004-02-24 | 15 | 0 |
| K032748 | VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE | Vital Images, Inc. | 2003-10-29 | 54 | 2 |
| K003639 | VITREA 2 CT PERFUSION OPTION | Vital Images, Inc. | 2001-01-23 | 60 | 0 |
| K003230 | V SCORE WITH AUTO GATE MODEL TBD | Vital Images, Inc. | 2000-12-27 | 72 | 0 |
| K002519 | VITREA 2, VERSION 2.1 | Vital Images, Inc. | 2000-10-19 | 65 | 1 |
| K001682 | VSCORE WITH EKG SIGNAL GATING | Vital Images, Inc. | 2000-06-30 | 29 | 0 |
| K990442 | ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 | Vital Images, Inc. | 1999-05-11 | 90 | 0 |
| K953259 | VOXELVIEW | Vital Images, Inc. | 1995-11-24 | 135 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda