510(k) · Cleared
Recalled · Class II · 2016Syngo RT Therapist Connect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYE Accelerator, Linear, Medical
Cleared on May 8, 2009 as substantially equivalent to K072485 (Siemens Medical Solutions USA, Inc., 2007) and 2 other predicates after a 53-day review. Its family tree reaches back 10 generations to 1992. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- May 8, 2009
- Review
- 53 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 10 generations to K914698 (1992). 46 ancestors in all, the oldest K862339 (1986). 7 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 6 generations between
- 3 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- This deviceK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK102671 Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK103606 Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · cites it directly · 3 of its ownK123812 Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity…Siemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 3 of its ownK121295 Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK132935 Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace…Siemens Medical Solutions USA, Inc. · 2014
Show all 10 generations
- Root · 10 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 9 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 8 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 7 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 6 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 4 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 3 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- This deviceK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010 · cites it directly5descendants
- K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · 2 generations on4descendants
- K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc. · 2013 · cites it directly3descendants
- K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on3descendants
- K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −9 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −8 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −7 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −6 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −5 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −3 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| −2 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| −1 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K102671 | Syngo RT Therapist Connect Workspace, V4.2 | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +2 | K103606 | Artiste Solution with Sys_VB50 Update | Siemens Medical Solutions USA, Inc. | 2011 | 7 |
| +1 | K123812 | Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for… | Siemens Medical Solutions USA, Inc. | 2013 | 9 |
| +3 | K121295 | Artistetm Solution with Sys Vcio | Siemens Medical Solutions USA, Inc. | 2012 | 5 |
| +2 | K132935 | Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1… | Siemens Medical Solutions USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K072485 | Artiste MV SASummary page 1…P~ro~duct ;IoC C)(le.;ravlt~c ARTISTETM Solution (aka K072485 December 27, ARTISTE MV) with the 2007… | 2007 |
| * | K060226 | Oncor ExpressionSummary page 1…2007 syn go®RT Therapist workspace ONCORTm Expression with K060226 March 15, COHERENCETm RT Therapist 2006… | 2006 |
| * | K082775 | Prescision OptionSummary page 1…OHERENCETm RT Therapist 2006 works pace PreScisionTM Option K082775 February 19 2009 Siemens Medical So… | 2009 |
What descends from it? (7)
2 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 |
|---|---|---|---|---|
| Jul 26, 2016 | Class II | Z-2878-2016 | Software design | Software patch installation to address several safety issues. |
| Aug 5, 2015 | Class II | Z-2812-2015 | Software design (manufacturing process) | A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients. |
| Feb 14, 2012 | Not classified | Z-1270-2012 | Device Design | Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A |
| Jun 29, 2010 | Not classified | Z-1523-2011 | Other | A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 20 of the 46 ancestors have a recall of any class.
- Of its descendants, K102671 (Siemens Medical Solutions USA, Inc., 2010) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K072485.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer: The syngo®Suite for Oncology Workspaces: The syngo®workspaces includes a number of syngo®based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also.permit patient data…
Read the full statement (138 words)
The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer:
The syngo®Suite for Oncology Workspaces:
The syngo®workspaces includes a number of syngo®based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also.permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
The svngo®RT Therapist Connect Workspace:
The syngo®RT Therapist Connect Workspace contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatmint recording. The syngO®RT Therapist Connect Workspace is an option when third party OIS, Treatment Planning Systems and/or PACS devices conforming to the DICOM® Standard are intended to be used in conjunction with the Siemens branded Linear Accelerator system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090683: Syngo RT Therapist Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090683
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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