# K192065: Syngo.Via RT Image Suite

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 18, 2019 after 48 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K971684 (1997). 217 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K173635: syngo.via RT Image Suite, Siemens Medical Solutions USA, Inc. (2018) Summary page 4.

## Most influential descendants
- K201444: Syngo.via RT Image Suite (2020), 5 descendants of its own
- K211379: syngo.via RT Image Suite (2021), 4 descendants of its own
- K220783: syngo.via RT Image Suite (2022), 3 descendants of its own
- K232799: syngo.via RT Image Suite (2024), 2 descendants of its own
- K260207: Multimodality Simulation Workspace (MM Sim) (v1.0.0) (2026), 0 descendants of its own

## Recalls of this device
- Aug 19, 2020 · Class II · Z-3005-2020: Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recogniz
- Jun 24, 2020 · Class II · Z-2688-2020: If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthe

## Indications for use
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment 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 efficiently 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 and modify simple treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools: * Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET. PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions *» Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT) * Frechand and semi-automatic contouring of regions-of-interest on any orientation including oblique * Creation of contours on any type of images 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 the user in comparing images and contours of different patients * 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 » Management of simple treatment plans * Generation of a synthetic CT based on multiple pre-define MR acquisitions

Source page: https://510kreport.com/device/K192065
Methodology: https://510kreport.com/methodology