510(k) · Cleared
Recalled · Class II · 2019Oncor Expression
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 15, 2006 as substantially equivalent to K031764 (Siemens Medical Solutions USA, Inc., 2003) and 3 other predicates after a 44-day review. Its family tree reaches back 7 generations to 1992. 13 later devices descend from it. It has been recalled 72 times.
- Decided
- Mar 15, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 72
- Predicates
- 4
Its longest line of descent runs back 7 generations to K914698 (1992). 28 ancestors in all, the oldest K862339 (1986). 13 later devices descend from it, 7 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 deviceK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 11 of its ownK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · cites it directly · 9 of its ownK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- 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
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K072485Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · cites it directly11descendants
- K082775Prescision OptionSiemens Medical Solutions USA, Inc. · 2009 · cites it directly9descendants
- K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · cites it directly7descendants
- 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
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) | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| +1 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | 4 |
| +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 |
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 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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…t Code: lYE Substantial Equivalence Claimed To: PRODUCT Clearance Claim of Equivalence For: ONCOR Avant-Garde with K031764 ONCOR Expression linear accelerator with COHERENCE COHERENCE Workspaces Workspaces, includes the… | 2003 |
| * | K993425 | PrimusSummary page 1…PRIMEVIEW3i is the version for use with the PRIMUS product line. PRIMUS K993425 ONCOR Expression linear accelerator LEONARDO K040970 Syngo based applications on COHERENCE Wo… | 1999 |
| * | K040970 | LeonardoSummary page 1…product line. PRIMUS K993425 ONCOR Expression linear accelerator LEONARDO K040970 Syngo based applications on COHERENCE Workspaces Siemens Siremobile Iso-C 3D K040347 3D Cone Beam Reconstruction… | 2004 |
| * | K040347 | Siremobil Iso-C 3DSummary page 1…ONCOR Expression linear accelerator LEONARDO K040970 Syngo based applications on COHERENCE Workspaces Siemens Siremobile Iso-C 3D K040347 3D Cone Beam Reconstruction Specifically 3D reconstruction application. Description Summary: Within the submission th… | 2004 |
| † | K010938 | Syngo Multimodality Workstation | 2001 |
| † | K972275 | Lantis Treatstation | 1997 |
What descends from it? (13)
See all 137 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072485 | Artiste MV SA | 2007 | 11 |
| K082775 | Prescision Option | 2009 | 9 |
| K090683 | Syngo RT Therapist Connect | 2009 | 7 |
| K102671 | Syngo RT Therapist Connect Workspace, V4.2 | 2010 | 5 |
| K092145 | 160MLC Option | 2009 | 4 |
| K123812 | Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens… | 2013 | 3 |
| K083502 | Panther Realart, Model 4.7 | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2019 | Class II | Z-2198-2019 | Other | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability |
| 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-1400-2018 | 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, 2018 | Class II | Z-1399-2018 | 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-1491-2017 | Software design | Software update |
| Jan 25, 2017 | Class II | Z-1214-2017 | 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… |
| Nov 19, 2014 | Class II | Z-0984-2015 | Software design | There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue. |
| Oct 23, 2013 | Class II | Z-0437-2014 | Device Design | A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there… |
| 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. |
| Apr 4, 2013 | Class II | Z-1182-2013 | Software design | Software update to fix multiple safety related issues. |
| Apr 4, 2012 | Not classified | Z-1494-2012 | Process control | The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract… |
| Apr 3, 2012 | Not classified | Z-1486-2012 | Software design | SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control. |
| Jan 22, 2012 | Not classified | Z-1092-2012 | Software design | Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment. |
| Nov 9, 2011 | Not classified | Z-0459-2012 | Component design/selection | Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line. |
| Jun 3, 2011 | Not classified | Z-3003-2011 | Software design | A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image. |
| May 25, 2011 | Not classified | Z-2789-2011 | Software design | Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system |
| Mar 31, 2011 | Not classified | Z-2216-2011 | Software design | Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review. |
| Mar 31, 2011 | Not classified | Z-2243-2011 | Software design | Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location. |
| Mar 24, 2011 | Not classified | Z-2190-2011 | Pending | When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment. |
| 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. |
| Mar 6, 2009 | Not classified | Z-2000-2011 | Software change control | The product has a software problem; it does not calculate the Creatinine Clearance correctly for patients less than two years old. |
| May 15, 2008 | Not classified | Z-2100-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2097-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2098-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2104-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2096-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2095-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2101-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2103-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2102-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| May 15, 2008 | Not classified | Z-2099-2008 | Software design | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| Jan 11, 2008 | Not classified | Z-1400-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Dec 10, 2007 | Not classified | Z-1761-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1760-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1762-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1763-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Nov 6, 2007 | Not classified | Z-0099-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0092-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0089-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0091-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0093-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0094-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0097-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0090-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0095-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0098-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Nov 6, 2007 | Not classified | Z-0096-2009 | Software design | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
The 5 latest of 50 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 14 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 11 of the 28 ancestors have a recall of any class.
- Of its descendants, K072485 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 11 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 ONCOR Expression TM linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Expression includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUETM 10OOST. The indications for use for the OPTIVUE 1000ST is the acquisition of portal images for the purpose of verification of the treatment field and shielding blocks in relation to patient positioning markers…
Read the full statement (295 words)
The intended use of the ONCOR Expression TM linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ONCOR Expression includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUETM 10OOST. The indications for use for the OPTIVUE 1000ST is the acquisition of portal images for the purpose of verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE 10OOOST will also allow for verification of the exit dose in radiotherapy treatment. The indications for use remain unchanged from the previously cleared OPTIVUE EPID (K031764).
Additionally, the ONCOR Expression includes as a standard feature, an 82 leaf multi-leaf collimator that is marketed as OPTIFOCUSTM. The OPTIFOCUS MVLG 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. The indications for use of the OPTIFOCUS MVLC remains unchanged from the previously cleared OPTIFOCUS MVLC (K031764).
The COHERENCETM Workspaces:
The COHERENCE Therapist workspace includes a number of syngoTM based software applications who's indication for use include the viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist Workspace also permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.
The Therapist Workspace in this release includes MVisionTM which consists of the Megavoltage Cone Beam imaging method for acquiring 20 projection data that is reconstructed by the Cone Beam reconstruction method into 3D data for use by the Adaptive TargetingTM application for advanced treatment localization and patient positioning. Adaptive Targeting can also use 3D data imported from other devices. The indications for use for the COHERENCE Therapist workspace remains unchanged from the previously cleared COHERENCE Therapist workspace (K031764).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060226 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060226: Oncor Expression.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060226
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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