# K052632: VITREA2 Version 3.8 Medical Image Processing Software

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Dec 15, 2005 after 80 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: 7 generations back to K913770 (1991). 23 ancestors in all.
117 later devices descend from it; 5 cite it directly.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043333: VITREA2, Version 3.7 Medical Image Processing System, Vital Images, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool (2009), 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
- 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
Vitrea2 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. Cardiac Functional Analysis (CFA) The CT CFA 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 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. Coronary Artery Analysis The separately-licensed CT Cardiac option includes CT Coronary Artery Analysis, which is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive survey of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics. 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. Vessel Probe The separately-licensed general Vessel Probe option is intended for determining the presence and extent of peripheral vascular obstructive disease by providing a non-invasive survey of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard Vitrea software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on a ratio of the smallest to the largest diameter. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Houndsfield unit or signal intensity statistics. VScore 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.

Source page: https://510kreport.com/device/K052632
Methodology: https://510kreport.com/methodology