510(k) · Cleared
Recalled · Class II · 2020Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0
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 1, 2006 as substantially equivalent to K031764 (Siemens Medical Solutions USA, Inc., 2003) and 2 other predicates after a 53-day review. Its family tree reaches back 7 generations to 1992. 5 later devices descend from it. It has been recalled once.
- Decided
- May 1, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K914698 (1992). 28 ancestors in all, the oldest K862339 (1986). 5 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 6 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 5 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 4 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 3 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- This deviceK060633 Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace…Siemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK103606 Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · 2 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
- Descendant · 3 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 · 4 generations on · 0 of its ownK182050 Linear Accelerator Control Console Software v13.1.010 Update, syngo…Siemens Medical Solutions USA, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · cites it directly4descendants
- K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012 · 2 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
- K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc. · 2014 · 3 generations on1descendant
- K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −6 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −5 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −4 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −3 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −2 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| 0 (this device) | K060633 | Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K103606 | Artiste Solution with Sys_VB50 Update | Siemens Medical Solutions USA, Inc. | 2011 | 7 |
| +2 | 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 | — |
| +3 | K142434 | Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT… | Siemens Medical Solutions USA, Inc. | 2014 | 5 |
| +4 | 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 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K031764 | Oncor Avant-Garde with Coherence WorkspacesSummary page 1…roduct Code: lYE Substantial Equivalence Claimed To: PRODUCT Clearance Claim of Equivalence For: ONCOR Avant-Garde with K031764 COHERENCE Workspaces, includes the addition of the COHERENCE Workspaces COHERENCE Physicist and a… | 2003 |
| * | K040970 | LeonardoSummary page 1…COHERENCE Physicist and an upgrade to the Oncologist workspaces. LEONARDO K040970 Syngo based applications on COHERENCE Workspaces RIT 113 K935928 Quality Assurance softwar… | 2004 |
| * | K935928 | Rit 113 Film Analysis SystemSummary page 1…workspaces. LEONARDO K040970 Syngo based applications on COHERENCE Workspaces RIT 113 K935928 Quality Assurance software applications. Description Summary: Within the submission the following internal naming co… | 1994 |
| † | K010938 | Syngo Multimodality Workstation | 2001 |
| † | K993425 | Primus | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103606 | Artiste Solution with Sys_VB50 Update | 2011 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2020 | Class II | Z-1346-2020 | Software Design Change | A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 10 of the 28 ancestors have a recall of any class.
- Of its descendants, K103606 (Siemens Medical Solutions USA, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K031764.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 COHERENCE Workspaces are as optional accessories to the linear accelerator systems to aid and support in the quality assurance, planning and delivery of x-ray radiation for the therapeutic treatment of cancer. The COHERENCE Workspaces encompasses a number of syngo software applications who's indication for use include the viewing, manipulation, filming, communications, and archiving of medical images and data on exchange media.…
Read the full statement (170 words)
The intended use of the COHERENCE Workspaces are as optional accessories to the linear accelerator systems to aid and support in the quality assurance, planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
The COHERENCE Workspaces encompasses a number of syngo software applications who's indication for use include the viewing, manipulation, filming, communications, and archiving of medical images and data on exchange media.
The COHERENCE Oncologist Workspace permits localization, contouring, image calibration and conditioning, and review of treatment parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy. The indications for use for the COHERENCE Oncologist 2.0 workspace remain unchanged from the previously cleared COHERENCE Oncologist workspace (K031764).
The COHERENCE Physicist Workspace is a syngo software application package for the use with radiation therapy devices for viewing, manipulation, image calibration and conditioning, communication and storage of medical images and data on exchange media; and as a quality assurance tool for radiation therapy linear accelerators and their accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060633: Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060633
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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