510(k) · Cleared
ClearedSiemens Virtual Simulation (Vsim)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Nov 5, 2002 as substantially equivalent to K013112 (Computerized Medical Systems, Inc., 2001) and 1 other predicate after a 134-day review. Its family tree reaches back 5 generations to 1992. 32 later devices descend from it.
- Decided
- Nov 5, 2002
- Review
- 134 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914698 (1992). 15 ancestors in all, the oldest K894706 (1989). 32 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 4 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 3 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 2 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 1 generation backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- This deviceK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 19 of its ownK061097 Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 18 of its ownK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- Descendant · cites it directly · 16 of its ownK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 13 of its ownK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 11 of its ownK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K061097Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · cites it directly19descendants
- K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010 · 2 generations on18descendants
- K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · cites it directly16descendants
- K060226Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on13descendants
- K072485Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −4 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −3 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −2 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −1 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| 0 (this device) | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K061097 | Coherence Dosimetrist, Model 2.2 | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| +2 | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | 1 |
| +1 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| +2 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| +3 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013112 | Focal Sim | 2001 |
| * | K923851 | Acqsim Simulator/LocalizerSummary page 1…Radiation Therapy Treatment Substantial equivalence claimed to: KO 13 1 12, FocalSim, Computerized Medical Systems, Inc. K92385 1 , ACQSM, Philips Medical Systems(Cleveland), Inc. Description: Siemens Virtual Simulation (VSim) is a s… | 1992 |
What descends from it? (32)
See all 322 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K061097 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K013112.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
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…
Read the full statement (126 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022036 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022036: Siemens Virtual Simulation (Vsim).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022036
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026