# K043333: VITREA2, Version 3.7 Medical Image Processing System

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Images, Inc.
- Decided: Dec 15, 2004 after 12 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 22 ancestors in all.
143 later devices descend from it; 5 cite it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040305: VITREA2 Version 3.5, Vital Images, Inc. (2004) Summary page 1.
- K032748: VITREA2, Version 3.4 Medical Image Processing Software, Vital Images, Inc. (2003) Summary page 1.
- K023760: CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B, Toshiba America Medical Systems, In.C (2002) Summary page 1.
- K023003: Imagechecker-CT Workstation, R2 Technology, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K073156: Qplaque MR (2008), 21 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own

## Recalls of this device
- Mar 15, 2013 · Class II · Z-1144-2013: Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values ma

## Indications for use
Vitrea 2 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. In addition, the Vitrea2 Version 3.7 has the following additional indications: CT Colonography The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view. CT Cardiac The separately-licensed CT Cardiac option contains two components: Coronary Artery Analysis and Cardiac Functional Analysis. The Vital Images' CT Cardiac option provides a variety of tools and views for working with clinical CT images of the coronary arteries, heart, and surrounding tissue. Coronary Artery Analysis The Coronary Artery Analysis component of the Vitrea CT Cardiac option is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive approach to survey a patient's coronary arteries. The vessel probe technology integrated into the CT Cardiac option allows physicians' to click on an artery to simultaneously view the following: the highlighted vessel in 3D, two curved vessel views orthogonal to each other, and cross-sectional views. Cardiac Functional Analysis The Cardiac Functional Analysis (CFA) component of the Vitrea CT Cardiac option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CFA component of the CT Cardiac option includes semi-automatic heart and left ventricle segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots. Lung Analysis The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

Source page: https://510kreport.com/device/K043333
Methodology: https://510kreport.com/methodology