510(k) · Cleared
Recalled · Class II · 2014Syngo Dosimetrist Workspace V2.7 Model: 1056864
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 Jun 16, 2010 as substantially equivalent to K061097 (Siemens Medical Solutions USA, Inc., 2006) and 3 other predicates after a 56-day review. Its family tree reaches back 7 generations to 1992. 18 later devices descend from it. It has been recalled once.
- Decided
- Jun 16, 2010
- Review
- 56 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K914698 (1992). 55 ancestors in all, the oldest K841997 (1984). 18 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 6 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 5 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 4 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 3 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK061097 Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- This deviceK101119 Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK162370 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016
- Descendant · cites it directly · 8 of its ownK151887 syngo VSimSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK173635 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 3 generations on · 6 of its ownK192065 Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015 · cites it directly9descendants
- K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016 · cites it directly8descendants
- K151887syngo VSimSiemens Medical Solutions USA, Inc. · 2015 · cites it directly8descendants
- K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on7descendants
- K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −6 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −5 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −4 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −3 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −2 | 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 |
| 0 (this device) | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +1 | K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +1 | K151887 | syngo VSim | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +2 | K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +3 | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2019 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K061097 | Coherence Dosimetrist, Model 2.2Summary page 1…ode: MUJ Substantial Equivalence Claimed To: PRODUCT Clearance Claim of Equivalence For: SIEMENS COHERENCE TM K061097 The Siemens syngo® Dosirnetrist Workspace v2.7 Dosimetrist Workspace v2.2 SIEMENS syngo®)CT K07131 0… | 2006 |
| * | K071310 | Syngo CT Oncology Software PackageSummary page 1…valence For: SIEMENS COHERENCE TM K061097 The Siemens syngo® Dosirnetrist Workspace v2.7 Dosimetrist Workspace v2.2 SIEMENS syngo®)CT K07131 0 Auto Segmentation using the Random Walker algorithm ONCOLOGY Software for automated volume s… | 2007 |
| * | K080799 | Atlas-Based AutosegmentationSummary page 1…mentation using the Random Walker algorithm ONCOLOGY Software for automated volume segmentation. Package Computerized Medical K080799 Auto-segmentation using predefined contours based on Systems, Inc. anatomical libraries… | 2008 |
| * | K061006 | IkoengeloSummary page 1…application for atlas based segmentation using deformable registration algorithms. IKOEtech, LLC, K061006 Automatic contour delineation to support the radiotherapy lKOEngeloTM treatment plann… | 2006 |
What descends from it? (18)
See all 186 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2014 | Class II | Z-2075-2014 | Software design | 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 the selected name from the list of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 13 of the 55 ancestors have a recall of any class.
- Of its descendants, K151380 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 9 descendants of its own.
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. 2010, this device’s year, is highlighted.
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 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…
Read the full statement (335 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101119
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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