Vital Images, Inc.
Vital Images, Inc. holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2018, with 5 FDA device recalls on record.
Top product codes for Vital Images, Inc.
FDA recalls by Vital Images, Inc.
- Z-0169-2014 — 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 a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.
- Z-1181-2013 — 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 evaluate areas of brain perfusion.
- Z-1144-2013 — 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, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.
- Z-1002-2013 — 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 the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
- Z-0186-2013 — 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, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Vital Images, Inc.
- K181247 — Vitrea CT Brain Perfusion
- K182230 — Multi Modality Viewer
- K172855 — Vitrea Advanced Visualization, Version 7.6
- K163232 — Vitrea View
- K163574 — Multi Modality Viewer
- K161157 — Vitrea CT Dual Energy Image View
- K161419 — Multi Modality Viewer
- K160150 — Vitrea CT Colon Analysis
- K151283 — Lung Analysis Software
- K151919 — Vitrea CT Lung Density Analysis Software
- K151115 — MR Core Software
- K150104 — Vitrea CT Myocardial Perfusion
- K150738 — VitreaView
- K150258 — Vitrea, Version 7.0 Medical Image Processing Software
- K143079 — Endovascular Stent Planning Software
- K141302 — VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
- K140395 — VITREA IMAGE DENOISING SOFTWARE
- K122578 — VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
- K121213 — VITREAADVANCED
- K122136 — VITREAVIEW
- K112531 — VITREA CT MYOCARDIAL ANALYSIS
- K111892 — VITREAVIEW SOFTWARE 6.1
- K091498 — VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
- K072821 — VITREA 4DCT
- K071362 — VITAL CONNECT 4.1
- K071331 — VITREA VERSION 4.0
- K062328 — VITREAACCESS, VERSION 1.0
- K062154 — VITAL CONNECT 4.0
- K061624 — VITREA, VERSION 3.9
- K060378 — VITREA2 VERSION 3.8.1
- K052632 — VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
- K043333 — VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
- K040876 — ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE
- K040305 — VITREA2 VERSION 3.5
- K032748 — VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
- K003639 — VITREA 2 CT PERFUSION OPTION
- K003230 — V SCORE WITH AUTO GATE MODEL TBD
- K002519 — VITREA 2, VERSION 2.1
- K001682 — VSCORE WITH EKG SIGNAL GATING
- K990442 — ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
- K953259 — VOXELVIEW
Data sourced from openFDA. This site is unofficial and independent of the FDA.