# K071331: Vitrea Version 4.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Images, Inc.
- Decided: May 25, 2007 after 14 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: 9 generations back to K913770 (1991). 34 ancestors in all.
82 later devices descend from it; 15 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061624: Vitrea, Version 3.9, Vital Images, Inc. (2006) Summary page 1.
- K051840: Ensite Verismo Software, St Jude Medical (2005) Summary page 1.
- K031261: Card EP, GE Medical Systems (2003) Summary page 1.
- K043111: Plaqueview Software, Model CSPV-0001A, Toshiba America Medical Systems, In.C (2004) Summary page 1.

## Most influential descendants
- K073156: Qplaque MR (2008), 21 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K072821: Vitrea 4DCT (2008), 17 descendants of its own
- K122429: Vessel Analysis and Autoplaque for Ors Visual (2012), 16 descendants of its own
- K150258: Vitrea, Version 7.0 Medical Image Processing Software (2015), 15 descendants of its own

## Recalls of this device
- Nov 11, 2011 · Not classified · Z-0388-2012: Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Sui

## Indications for use
Vitrea 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. Vitrea is not meant for primary Image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indication: Cardiac EP Planning is a post processing advanced visualization application that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite®System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy. The SUREPlaque Tm software application is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. This software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels. The Vessel Probe option is intended for viewing the anatomy and pathology 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 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 or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.

Source page: https://510kreport.com/device/K071331
Methodology: https://510kreport.com/methodology