# K032748: VITREA2, Version 3.4 Medical Image Processing Software

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Images, Inc.
- Decided: Oct 29, 2003 after 54 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913770 (1991). 10 ancestors in all.
170 later devices descend from it; 4 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000) Summary page 1.
- K020483: Advantage Workstation 4.1, GE Medical Systems (2002) Summary page 1.
- K023003: Imagechecker-CT Workstation, R2 Technology, Inc. (2002) Summary page 1.
- K013381: Advanced Lung Analysis-1, General Electric Co. (2001) Summary page 1.

## Most influential descendants
- K040305: VITREA2 Version 3.5 (2004), 164 descendants of its own
- K043333: VITREA2, Version 3.7 Medical Image Processing System (2004), 143 descendants of its own
- K052632: VITREA2 Version 3.8 Medical Image Processing Software (2005), 117 descendants of its own
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own
- K071331: Vitrea Version 4.0 (2007), 82 descendants of its own

## Recalls of this device
- Mar 15, 2013 · Class II · Z-1181-2013: Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide covera
- Aug 13, 2012 · Class II · Z-0186-2013: Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitre

## Indications for use
Vitream2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, VitreaTM2 has the following specific indications. VScorem (K990442) is an option within the VitreaT‘2 application and 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 (K001682) and Auto Gate (K003230), allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring. Automated Vascular Measurement (KO02519) is an option within the VitreaTM2 application and is intended for study/analysis of selected vessels for stenosis analysis, prelpost stent planning and directionalvessel tortuosity evaluation. Tumor Volume Measurement (K002519) is an option within the VitreaTM2 application and is intended for the analysislquantification of tumor volumes obtained from MR brain series scans. CT Brain Perfusion (K003639) is an option within the VitreaTM2 application and is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances. ImageCheckerCT is an option within the VitreaTM2 application and is intended for the display of a composite view of 2 0 cross-sections, and 3D volumes of Chest CT images, including findings of regions of interest (“ROI”) identified by the radiologist, or Computer Assisted Detection (“CAD”) findings.

Source page: https://510kreport.com/device/K032748
Methodology: https://510kreport.com/methodology