# K121213: Vitreaadvanced

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Nov 2, 2012 after 196 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: 11 generations back to K913770 (1991). 99 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 1.
- K090504: CSBP-001A Body Perfusion System, Toshibamedical Systems Corporation (2009) Summary page 1.
- K051528: Mevis Liveranalyser/Liverviewer Software, Mevis Technology GmbH & Co. KG (2005) Summary page 1.
- K071241: LMS-Liver, Median Technologies (2007) Summary page 1.
- K072821: Vitrea 4DCT, Vital Images, Inc. (2008) Summary page 1.
- K073238: Syngo Volume Perfusion-CT Neuro, Siemens AG Medical Solutions (2008) Summary page 5.

## Most influential descendants
- K142521: Synapse 3D Liver and Kidney Analysis (2014), 5 descendants of its own
- K151988: Visible Patient Suite (2015), 4 descendants of its own
- K212896: Visible Patient Suite (2021), 3 descendants of its own
- K250237: InferOperate Suite (2025), 1 descendant of its own
- K260973: InferOperate Suite (2026), 0 descendants of its own

## Recalls of this device
- Mar 15, 2013 · Class II · Z-1181-2013: Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide covera

## Indications for use
Vitreadvanced is a medical diagnostic system for the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitreadvanced is not meant for primary image interpretation in mammography. It can be used with a variety of cleared Vitrea® based software applications. In addition, Vitreadvanced includes three Vitrea® applications: Vitrea® CT Body Perfusion is a noninvasive post-processing application designed to evaluate perfusion of organs and tumors. The software can calculate perfusion characteristics from dynamic CT image data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and venous components of perfusion in organs. It supports evaluation of regions of interest and the visual inspection of time density curves. When used by a trained and qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring. Vitrea® CT Liver Analysis is a noninvasive post-processing application designed to evaluate liver tumors and plan for liver surgery. It displays images for analysis and preoperative liver surgery planning, such as organ segmentation, tumor segmentation and intrahepatic vessels segmentation, as well as the approximation of vascular territories. It supports preoperative evaluation of specific surgery strategies by allowing the user to interactively define virtual resections splitting the liver. It also allows the user to evaluate safety-margins around lesions and to identify affected vascular branches and territories. Vitrea® CT Liver Analysis also provides automatic registration of multiple series and measurement tools for characterization and follow-up of the lesions. When used by a trained and qualified physician a potential application is to assist in the assessment of tumor response to therapy. Vitrea® CT Brain Perfusion is a noninvasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time density curves. Vitrea® CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).

Source page: https://510kreport.com/device/K121213
Methodology: https://510kreport.com/methodology