510(k) · Cleared
Clearedsyngo.via RT Image Suite
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 Oct 25, 2016 as substantially equivalent to K151380 (Siemens Medical Solutions USA, Inc., 2015) and 1 other predicate after a 62-day review. Its family tree reaches back 11 generations to 1991. 8 later devices descend from it.
- Decided
- Oct 25, 2016
- Review
- 62 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 167 ancestors in all, the oldest K841997 (1984). 8 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 1 generation backK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
- This deviceK162370 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK173635 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK192065 Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 5 of its ownK201444 Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 4 generations on · 4 of its ownK211379 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 5 generations on · 3 of its ownK220783 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 1 generation backK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
- This deviceK162370 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018 · cites it directly7descendants
- K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019 · 2 generations on6descendants
- K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on5descendants
- K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · 4 generations on4descendants
- K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −1 | K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015 | — |
| 0 (this device) | K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +1 | K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2019 | 2 |
| +3 | K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +4 | K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2021 | 2 |
| +5 | K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 7 | 0 |
| 1998 | 14 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 6 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 9 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K151380 | syngo.via RT Image SuiteSummary page 5…MUJ Subsequent Product Code: LLZ III. Predicate Device Primary Predicate Device: Trade Name: syngo.via RT Image Suite 510(k) Number: K151380 Clearance Date: August 13, 2015 Classification Name: System, Planning, Radiation Therapy Treatment Classification… | 2015 |
| * | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864Summary page 5…There have been no recalls for this device Secondary Predicate Device: Trade Name: syngo Dosimetrist Workspace v2.7 510(k) Number: K101119 Clearance Date: October 9, 2010 Classification Name: System, Planning, Radiation Therapy Treatment Classification Pa… | 2010 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173635 | syngo.via RT Image Suite | 2018 | 7 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 42 of the 167 ancestors have a recall of any class.
- Of its descendants, K173635 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 7 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. 2016, 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?
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to efficiently view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to…
Read the full statement (238 words)
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).
It provides tools to efficiently view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System.
The software combines following digital image processing and visualization tools:
• Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
• Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
• Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• Creation of contours on any type of images without prior assignment of a planning CT
• Manual and semi-automatic registration using rigid and deformable registration
• Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
• Supports the user in comparing images and contours of different patients
• Supports multi-modality image fusion
• Visualization and contouring of moving tumors and organs
• Management of points of interest including but not limited to the isocenter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162370: syngo.via RT Image Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162370
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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