510(k) · Cleared
Recalled · Class II · 13Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv
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 Mar 1, 2013 as substantially equivalent to K090683 (Siemens Medical Solutions USA, Inc., 2009) and 2 other predicates after an 80-day review. Its family tree reaches back 11 generations to 1992. 3 later devices descend from it. It has been recalled 9 times.
- Decided
- Mar 1, 2013
- Review
- 80 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 11 generations to K914698 (1992). 48 ancestors in all, the oldest K862339 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 7 generations between
- 3 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- This deviceK123812 Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity…Siemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK132935 Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace…Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK142434 Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT…Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK182050 Linear Accelerator Control Console Software v13.1.010 Update, syngo…Siemens Medical Solutions USA, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 10 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 9 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 8 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 7 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 6 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 5 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 4 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- This deviceK123812 Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity…Siemens Medical Solutions USA, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc. · 2014 · cites it directly2descendants
- K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on1descendant
- K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −10 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −9 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −8 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −7 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −6 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −5 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −4 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| −3 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| −2 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | 4 |
| 0 (this device) | K123812 | Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for… | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K132935 | Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +2 | K142434 | Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT… | Siemens Medical Solutions USA, Inc. | 2014 | 5 |
| +3 | K182050 | Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation… | Siemens Medical Solutions USA, Inc. | 2018 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K090683 | Syngo RT Therapist ConnectSummary page 1…51 0(k) Claim of Equivalence for: Clearance/ Date COHERENCETM PT K090683 / COHERENCETM PT Therapist Connect Workspace, for Therapist v2.l a with May 08, RT Therapist with Software… | 2009 |
| * | K092145 | 160MLC OptionSummary page 1…, RT Therapist with Software update Sys..YA32a (RTTC Control Console 9.2. 2009 v2.3) and Control Console 9.2. OpCORTM With 160MLC K092145/ I OHERENCPM PT Therapist Connect Workspace for Option with RTT v2.2 & with March 13, RT Therapist with Software u… | 2009 |
| * | K060226 | Oncor ExpressionSummary page 1…ch 13, RT Therapist with Software update SysVAS2a (RTTC Control Console 11.0. 2009 v2.3) and Control Console 11. ONCCRTM Expression with K060226/ COHERENCETM RT Therapist Connect Workspace for RTT v2.0± & with Control Mar. 15, RT Therapist with Software u… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132935 | Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit… | 2014 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 13 | Class II | Z-1042-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1038-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1037-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1040-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1041-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1043-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1036-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1039-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
| Mar 5, 13 | Class II | Z-1044-2013 | Software design (manufacturing process) | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 22 of the 48 ancestors have a recall of any class.
- Of its descendants, K132935 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K090683.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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.
COHERENCE RT Therapist is a component of the linear accelerator system and is based on the syngo architecture. It enables patient management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.
COHERENCE RT Therapist Workspace Connect v2.3 can be Interfaced with 3rd party devices conforming to the DICOM standard.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123812: Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123812
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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