# K060378: VITREA2 Version 3.8.1

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Images, Inc.
- Decided: Mar 9, 2006 after 23 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913770 (1991). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 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.
- K033955: RTIST, Mirada Solutions, Ltd. (2004) Summary page 1.
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002) Summary page 1.
- K040028: CA-1500, R2 Technology, Inc. (2004) Summary page 1.
- K041380: Imagechecker-CT Software Package with Filling Defect Indicator, R2 Technology, Inc. (2004) Summary page 1.

## Most influential descendants
- K120161: Alphapoint Imaging Software (2012), 0 descendants of its own

## 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. Vitrea2 Version 3.8.1 adds the following previously FDA-cleared software applications to the currently marketed Vitrea2 system: Fusion7D, RTist, ImageChecker CT Lung v2.0 System, AutoPoint Temporal Comparison Tool, and the Pulmonary Artery PE (Patency Exam).

Source page: https://510kreport.com/device/K060378
Methodology: https://510kreport.com/methodology