# K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 16, 2010 after 56 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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: 7 generations back to K914698 (1992). 55 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061097: Coherence Dosimetrist, Model 2.2, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K071310: Syngo CT Oncology Software Package, Siemens AG (2007) Summary page 1.
- K080799: Atlas-Based Autosegmentation, Computerized Medical Systems, Inc. (2008) Summary page 1.
- K061006: Ikoengelo, Ikoetech, LLC (2006) Summary page 1.

## Most influential descendants
- K151380: syngo.via RT Image Suite (2015), 9 descendants of its own
- K162370: syngo.via RT Image Suite (2016), 8 descendants of its own
- K151887: syngo VSim (2015), 8 descendants of its own
- K173635: syngo.via RT Image Suite (2018), 7 descendants of its own
- K192065: Syngo.Via RT Image Suite (2019), 6 descendants of its own

## Recalls of this device
- May 15, 2014 · Class II · Z-2075-2014: An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store 

## Indications for use
The intended use of syngo® Dosimetrist Workspace is as an accessory to the linear accelerator system to aid and support in the planning of delivery of x-ray photon and electron radiation for the therapeutic-treatment of cancer. The syngo®Dosimetrist Workspace v2.7 is a comprehensive oncology workflow software package that allows for both CT simulation as well as inverse radiation therapy treatment planning and optimization to aid in the oncology clinical workdflow where indicated. The syngo® Dosimetrist workspace is comprised of two major components, the CT Simulation component (VSIM) and the inverse radiation therapy treatment planning component (KonRad) to be used in the creation, modification, evaluation and approval of radiation treatment plans. The VSIM component permits CT simulation to be performed on the syngo© Dosimetrist workstation. The CT scans are imported into the VSIM software component and the user is able to create three-dimensional models of targets and organs. The VSIM application supports the use of automatic contouring and segmentation or a model based segmentation (MBS) library of anatomical regions may be used. The contours and segmentation can be manually adjusted prior to use by the treatment planning system. Additionally, the user is able to identify the patient isocenter, place treatment beams, and identify beam modifiers (blocks, apertures, and ML~s). The simulation information is then available for radiation treatment planning for dose calculation via the KonRad software component or other treatment planning systems. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment. The KonRad software component is intended to optimize multi-leaf (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (1IMRT). Once the optimization is complete, the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval, the results are exported to the delivery equipment, linear accelerator, or record and verify system, for final verification prior to treatment delivery. The KonRad TPS software component allows for efficient inverse radiation therapy treatment planning and optimization.

Source page: https://510kreport.com/device/K101119
Methodology: https://510kreport.com/methodology