# K022036: Siemens Virtual Simulation (Vsim)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 5, 2002 after 134 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: 5 generations back to K914698 (1992). 15 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013112: Focal Sim, Computerized Medical Systems, Inc. (2001)
- K923851: Acqsim Simulator/Localizer, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 1.

## Most influential descendants
- K061097: Coherence Dosimetrist, Model 2.2 (2006), 19 descendants of its own
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864 (2010), 18 descendants of its own
- K031764: Oncor Avant-Garde with Coherence Workspaces (2003), 16 descendants of its own
- K060226: Oncor Expression (2006), 13 descendants of its own
- K072485: Artiste MV SA (2007), 11 descendants of its own

## Indications for use
The SYNGO workstation encornpasses a number of software applications for viewing, processing, filming, and archiving of medical images. VSim is one of the software applications that are offered on the SYNGO workstation, KO1 093s. VSim permits CT Siniulation to be performed on the SYNGO workstation. The CT scans are first loaded into the VSim software. On VSim the user is able to create 3D models of targets and organs. On VSim the user is able to identify the patient isocenter, place treatment beams and identify beam modifiers (blocks, apertures, and MLCs). This information is then sent to a radiation treatment planning system for dose calculation. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.

Source page: https://510kreport.com/device/K022036
Methodology: https://510kreport.com/methodology