# K061624: Vitrea, Version 3.9

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Jun 27, 2006 after 15 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: 8 generations back to K913770 (1991). 29 ancestors in all.
111 later devices descend from it; 9 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)
- K052632: VITREA2 Version 3.8 Medical Image Processing Software, Vital Images, Inc. (2005) Summary page 1.
- K043111: Plaqueview Software, Model CSPV-0001A, Toshiba America Medical Systems, In.C (2004) Summary page 1.

## Most influential descendants
- 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
- K072821: Vitrea 4DCT (2008), 17 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
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. In addition, Vitrea2 Version 3.9 has the following additional indication: The SUREPlaque TM tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.

Source page: https://510kreport.com/device/K061624
Methodology: https://510kreport.com/methodology