# K120484: Visia Oncology

- Pathway: 510(k) (Traditional)
- Applicant: MeVis Medical Solutions AG
- Decided: Mar 27, 2012 after 39 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: 10 generations back to K913770 (1991). 49 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071310: Syngo CT Oncology Software Package, Siemens AG (2007) Summary page 2.
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 2.

## Most influential descendants
- K141745: Iqqa-Bodyimaging Software (2014), 6 descendants of its own
- K191530: StoneChecker (2019), 1 descendant of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K240620: Cube Navigator (2024), 0 descendants of its own
- K202084: DeepLook PRECISE (2021), 0 descendants of its own

## Indications for use
Visia Oncology is a medical software application intended for the visualization of images from a variety of image devices. The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia Oncology is a noninvasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.

Source page: https://510kreport.com/device/K120484
Methodology: https://510kreport.com/methodology