510(k) · Cleared
Recalled · Class II · 2020Syngo.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 Sep 18, 2019 as substantially equivalent to K173635 (Siemens Medical Solutions USA, Inc., 2018) after a 48-day review. Its family tree reaches back 15 generations to 1997. 5 of the 224 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 18, 2019
- Review
- 48 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 15 generations to K971684 (1997). 217 ancestors in all, the oldest K841997 (1984). 6 later devices descend from it, 1 citing it directly. 5 of the 224 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations between
- 3 generations backK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- 2 generations backK163234 Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK173635 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018
- This deviceK192065 Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK201444 Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK211379 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 3 of its ownK220783 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK232799 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK260207 Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V. · 2026
Show all 15 generations
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 14 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 13 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 11 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 10 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 9 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 8 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 7 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 6 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 5 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 4 generations backK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- 3 generations backK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- 2 generations backK163234 Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK173635 syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2018
- This deviceK192065 Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma…3 generations back · 2016
- K121434 Software Syngo MR D13A for the Magnetom Systems…3 generations back · 2012
- K151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit…4 generations back · 2015
- K101347 Magnetom Aera; Magnetom Skyra5 generations back · 2010
Most influential descendants
Showing 5 of 6 · See all- K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2020 · cites it directly5descendants
- K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on4descendants
- K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2022 · 3 generations on3descendants
- K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · 2024 · 4 generations on2descendants
- K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −14 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −13 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −12 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −11 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −10 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −9 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −8 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −7 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −6 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −5 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −4 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2015 | Class I |
| −3 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | Class I |
| −2 | K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −1 | K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018 | — |
| 0 (this device) | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +1 | K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2021 | 2 |
| +3 | K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +4 | K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +5 | K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 6 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 6 | 0 |
| 1998 | 16 | 0 |
| 1999 | 7 | 0 |
| 2000 | 14 | 0 |
| 2001 | 20 | 0 |
| 2002 | 17 | 0 |
| 2003 | 7 | 0 |
| 2004 | 17 | 0 |
| 2005 | 11 | 0 |
| 2006 | 13 | 0 |
| 2007 | 8 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
5 devices in this family have a Class I recall. 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 18.7 · 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? (1)
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 |
|---|---|---|---|
| * | K173635 | syngo.via RT Image SuiteSummary page 4…Class II Product Code: MUJ III. Predicate Device Predicate Device: Trade Name: syngo.via RT Image Suite 510(k) Number: K173635 Clearance Date: 01/12/2018 Classification Name: System, Planning, Radiation Therapy Treatment Classification Panel… | 2018 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201444 | Syngo.via RT Image Suite | 2020 | 5 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2020 | Class II | Z-3005-2020 | Software design | Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment… |
| Jun 24, 2020 | Class II | Z-2688-2020 | Software design | If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 62 of the 217 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K201444 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 5 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. 2019, 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 (269 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. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans 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)
* Frechand 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
» Management of simple treatment plans
* Generation of a synthetic CT based on multiple pre-define MR acquisitions
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/K192065 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192065: Syngo.Via RT Image Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192065
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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