# K040305: VITREA2 Version 3.5

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Feb 24, 2004 after 15 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: 5 generations back to K913770 (1991). 18 ancestors in all.
164 later devices descend from it; 3 cite it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032748: VITREA2, Version 3.4 Medical Image Processing Software, Vital Images, Inc. (2003) Summary page 1.
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002) Summary page 1.

## Most influential descendants
- K043333: VITREA2, Version 3.7 Medical Image Processing System (2004), 143 descendants of its own
- 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

## 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 Vitrea 2 system has the following specific indication: Fusion7D is an option within the Vitrea 2 system and is intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures. Softread, is an option within the Vitrea 2 system and is intended to allow the examination and manipulation of a series of 2D images in a variety of modalities, including CT, MR, CR/DRIDX, SC, US, NM, PET, XA, and RF, etc. The option also enables clinicians to compare multiple series' for the same patient, side-by-side, and to switch to Vitrea to further examine the data in a 3D volume.

Source page: https://510kreport.com/device/K040305
Methodology: https://510kreport.com/methodology