# K232799: syngo.via RT Image Suite

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 26, 2024 after 227 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K971684 (1997). 221 ancestors in all.
2 later devices descend from it; 2 cite it directly.
5 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220783: syngo.via RT Image Suite, Siemens Medical Solutions USA, Inc. (2022) Summary page 6.

## Most influential descendants
- K260207: Multimodality Simulation Workspace (MM Sim) (v1.0.0) (2026), 0 descendants of its own
- K252304: syngo.via RT Image Suite VC10 (2026), 0 descendants of its own

## Indications for use
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System. The software combines the following digital image processing and visualization tools: » Multi-modality viewing and contouring of anatomical, functional, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images » Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT) * Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique » Automated Contouring on CT images » Creation of contours on images supported by the application without prior assignment of a planning CT * Manual and semi-automatic registration using rigid and deformable registration » Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points » Supports multi-modality image fusion * Visualization and contouring of moving tumors and organs * Management of points of interest including but not limited to the isocenter * Creation of simple geometric treatment plans * Generation of a synthetic CT based on multiple pre-define MR acquisitions

Source page: https://510kreport.com/device/K232799
Methodology: https://510kreport.com/methodology