# K061097: Coherence Dosimetrist, Model 2.2

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 7, 2006 after 49 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: 6 generations back to K914698 (1992). 23 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022036: Siemens Virtual Simulation (Vsim), Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K022307: Konrad, Model V.2.0, Mrc Systems GmbH (2002) Summary page 1.

## Most influential descendants
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864 (2010), 18 descendants of its own
- 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

## Recalls of this device
- Nov 6, 2009 · Not classified · Z-1834-2011: A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. For the Target the user defines the max. dose a

## Indications for use
The COHERENCE Dosimetrist Workspace v2.2 is a comprehensive oncology worldlow software package that allows for both CT simulation as well as inverse radiation therapy treatment planning and optimization in one software package to aid in oncology clinical workflow. This workspace is comprised of two major components, the CT Simulation component (VSIM) and the inverse radiation therapy treatment planning component (KonRad). The VSIM component permits CT simulation to be performed on the syngo workstation. The CT scans are first loaded into the VSIM software component and the user is able to create three-dimensional models of targets and organs. The user is able to identify the patient isocenter, place treatment beams, and identify beam modifiers (blocks, apertures, and MLCs). The 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 (IMRT). 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 software component allows for efficient inverse radiation therapy treatment planning and optimization.

Source page: https://510kreport.com/device/K061097
Methodology: https://510kreport.com/methodology