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 Aug 13, 2015 as substantially equivalent to K101119 (Siemens Medical Solutions USA, Inc., 2010) and 1 other predicate after an 83-day review. Its family tree reaches back 10 generations to 1991. 9 later devices descend from it.
- Decided
- Aug 13, 2015
- Review
- 83 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 166 ancestors in all, the oldest K841997 (1984). 9 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK151380 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 · 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
- Descendant · 4 generations on · 5 of its ownK201444 Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 5 generations on · 4 of its ownK211379 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · Recalled
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK151380 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2016 · 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
- K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on5descendants
- K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| 0 (this device) | 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 | — |
| +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 |
| +4 | K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +5 | K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2021 | 2 |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864Summary page 5…Product Code: LLZ Legally Marketed Primary Predicate Device: Trade Name: syngo® Dosimetrist Workspace v2.7 510(k)#: K101119 Clearance Date: June 16, 2010 Classification Name: System, Planning, Radiation Therapy Treatment… | 2010 |
| * | K093621 | Syngo.Pet&CT OncologySummary page 5…Information: Recall 68395 Legally Marketed Secondary Predicate Device: Trade Name: syngo.PET&CT Oncology 510(k)#: K093621 Clearance Date: February 23, 2010 Classification Name: Picture Archiving and Communication Systems… | 2010 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162370 | syngo.via RT Image Suite | 2016 | 8 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 42 of the 166 ancestors have a recall of any class.
- Of its descendants, K162370 (Siemens Medical Solutions USA, Inc., 2016) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K101119.
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. 2015, 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 (214 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, and Linac Cone Beam CT (CBCT) images
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151380: 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/K151380
Report an extraction error
Are you the manufacturer?
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