510(k) · Cleared
Recalled · Class II · 2019Oncor Avant-Garde with Coherence Workspaces
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 Sep 5, 2003 as substantially equivalent to K993425 (Siemens Medical Solutions USA, Inc., 1999) and 7 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1992. 16 later devices descend from it. It has been recalled 17 times.
- Decided
- Sep 5, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 17
- Predicates
- 8
Its longest line of descent runs back 6 generations to K914698 (1992). 25 ancestors in all, the oldest K862339 (1986). 16 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 5 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 4 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 3 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 2 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- This deviceK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 11 of its ownK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 5 of its ownK102671 Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K060226Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · cites it directly13descendants
- K072485Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · 2 generations on11descendants
- K082775Prescision OptionSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on9descendants
- K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on7descendants
- K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −5 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −4 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −3 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −2 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −1 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| +2 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| +2 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | 4 |
| +2 | K102671 | Syngo RT Therapist Connect Workspace, V4.2 | Siemens Medical Solutions USA, Inc. | 2010 | — |
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 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K993425 | PrimusSummary page 1…Name: Accelerator, Linear, Medical Classification: 892.5050 Product Code: IYE Substantial Equivalence Claimed To: PRIMUS K993425 (equivalence for ONCOR Avant-Garde linear accelerator) Mevatron KD2 K862339 (equivalence for ONCOR Ava… | 1999 |
| * | K862339 | Mevatron KD-2Summary page 1…IYE Substantial Equivalence Claimed To: PRIMUS K993425 (equivalence for ONCOR Avant-Garde linear accelerator) Mevatron KD2 K862339 (equivalence for ONCOR Avant-Garde linear accelerator) BeamView K903139 (equivalence for OPTIVUE… | 1986 |
| * | K903139 | Beamview & Beamview Plus (Aka Project 743)Summary page 1…valence for ONCOR Avant-Garde linear accelerator) Mevatron KD2 K862339 (equivalence for ONCOR Avant-Garde linear accelerator) BeamView K903139 (equivalence for OPTIVUE Electronic Portal Imaging Device) PortalVision KO03636 (equivalence for OPTIV… | 1990 |
| * | K003636 | Portalvision | 2001 |
| * | K953894 | Siemens Multileaf CollimatorSummary page 1…for OPTIVUE Electronic Portal Imaging Device) PortalVision KO03636 (equivalence for OPTIVUE Electronic Portal Imaging Device) 58 leaf MLC K953894 (equivalence for OPTIFOCUS 82 leaf multi-leaf collimator) (VSIM) Dosimetrist KO22036 (equivalence for COHER… | 1995 |
| * | K022036 | Siemens Virtual Simulation (Vsim)Summary page 2…n of previously cleared functionality. The Therapist Workspace integrates various functions from previously cleared products (ie. VSlM marketed as COHERENCE Dosimetrist (K022036), syngo Workstation (KO10938), and LANTIS Treatstation marketed as PRIMEVIEW (K972275). The COHERENCE Therapist Workspace is desi… | 2002 |
| * | K010938 | Syngo Multimodality WorkstationSummary page 2…nts with access to pertinent treatment data allowing for full treatment review. The COHERENCE Oncologist Workspace is based on the previously cleared syngo architecture (K010938). The COHERENCE Oncologist Workspace is also based on functionality cleared under VSlM via KO22036 and permits localization, cont… | 2001 |
| * | K972275 | Lantis TreatstationSummary page 1…osimetrist KO22036 (equivalence for COHERENCE Workspaces) syngo Workstation KO10938 (equivalence for COHERENCE Workspaces) LANTIS Treatstation K972275 (equivalence for COHERENCE Workspaces) Description: Within the submission the following internal naming conventions a… | 1997 |
What descends from it? (16)
See all 163 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 |
|---|---|---|---|---|
| Mar 20, 2019 | Class II | Z-1204-2019 | Use error | Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field… |
| Feb 14, 2018 | Class II | Z-1398-2018 | Software design | Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table. |
| Feb 14, 2017 | Class II | Z-1490-2017 | Software design | Software update |
| Jan 25, 2017 | Class II | Z-1213-2017 | Device Design | Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension. |
| 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. |
| May 5, 2015 | Class II | Z-0168-2016 | Software design | potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option. |
| Dec 19, 2014 | Class II | Z-1059-2015 | Component design/selection | A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke… |
| Dec 2, 2014 | Class II | Z-0980-2015 | Component design/selection | Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose… |
| May 28, 2014 | Class II | Z-2174-2014 | Use error | A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision… |
| Apr 1, 2014 | Class II | Z-1645-2014 | Software design | Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. |
| May 29, 2013 | Class II | Z-1663-2013 | Process change control | The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients. |
| Nov 4, 2010 | Not classified | Z-2642-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Aug 21, 2009 | Not classified | Z-1970-2011 | Software design | When editing the note type of a previously entered note, then reverting to the original type, data may be lost. |
| Jan 11, 2008 | Not classified | Z-1399-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Oct 3, 2007 | Not classified | Z-1769-2008 | Software design | Software. The firm issued an Advisory Letter Update instruction TH030/07/S as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. The advisory alerts all its affected customers of the… |
| Mar 23, 2007 | Not classified | Z-0380-2008 | Device Design | Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force. |
| Mar 22, 2007 | Not classified | Z-0164-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
The 5 latest of 17 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 11 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 8 of the 25 ancestors have a recall of any class.
- Of its descendants, K060226 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K993425.
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 ONCOR Avant-Garde linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Avant-Garde includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUE and is used for the verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE will also allow for verification…
Read the full statement (276 words)
The intended use of the ONCOR Avant-Garde linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Avant-Garde includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUE and is used for the verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE will also allow for verification of the exit dose in radiotherapy treatment. Additionally, the ONCOR Avant-Garde includes an 82 leaf multi-leaf collimator that will be marketed as OPTIFOCUS. The OPTIFOCUS MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.
The COHERENCE Workspaces (Therapist and Oncologist) encompasses a number of syngo software applications for viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist and Oncologist Workspaces are two of the software applications that are offered on the syngo workstation (K010938). COHERENCE Therapist Workspace is included in the ONCOR Avant-Garde product. The Therapist Workspace permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.
The COHERENCE Oncologist Workspace permits localization, contouring, image 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031764: Oncor Avant-Garde with Coherence Workspaces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031764
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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