510(k) · Cleared
Recalled · Class II · 2020Artiste MV SA
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 Dec 27, 2007 as substantially equivalent to K060226 (Siemens Medical Solutions USA, Inc., 2006) after a 114-day review. Its family tree reaches back 8 generations to 1992. 11 later devices descend from it. It has been recalled 24 times.
- Decided
- Dec 27, 2007
- Review
- 114 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 24
- Predicates
- 1
Its longest line of descent runs back 8 generations to K914698 (1992). 29 ancestors in all, the oldest K862339 (1986). 11 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 7 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 6 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 5 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 4 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 2 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 1 generation backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- This deviceK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007
- 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 · cites it directly · 4 of its ownK103606 Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · cites it directly · 4 of its ownK092145 160MLC OptionSiemens Medical Solutions USA, Inc. · 2009 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- 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 · cites it directly4descendants
- K092145160MLC OptionSiemens Medical Solutions USA, Inc. · 2009 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −7 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −6 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −5 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −4 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −3 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −1 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| 0 (this device) | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +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 | — |
| +1 | K103606 | Artiste Solution with Sys_VB50 Update | Siemens Medical Solutions USA, Inc. | 2011 | 7 |
| +1 | K092145 | 160MLC Option | Siemens Medical Solutions USA, Inc. | 2009 | 11 |
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 |
|---|---|---|
| 2009 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K060226 | Oncor ExpressionSummary page 1…SATM Device classification: 892.5050/ IYE/Radiology Substantial equivalence claimed to: ONCOR EXPRESSION with COHERENCE Workspaces (K060226) Device Description: The ACCEL system is the internal name for the Siemens program which includes the ONCOR Linear Acce… | 2006 |
What descends from it? (11)
See all 116 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 |
|---|---|---|---|---|
| Feb 18, 2020 | Class II | Z-1677-2020 | Use error | Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| 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, 2017 | Class II | Z-1488-2017 | Software design | Software update |
| Jan 25, 2017 | Class II | Z-1212-2017 | 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. |
| 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… |
| Jun 17, 2014 | Class II | Z-2180-2014 | Software design | Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the… |
| 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-1652-2014 | Labeling design | Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models. |
| Apr 1, 2014 | Class II | Z-1645-2014 | Software design | Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. |
| Oct 23, 2013 | Class II | Z-0438-2014 | 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… |
| 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. |
| 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. |
| Dec 3, 2010 | Not classified | Z-1422-2011 | Other | The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient. |
| 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. |
| Jan 22, 2010 | Not classified | Z-0449-2011 | Other | The robotic lift armature shaft may break and allow the Flat Panel Positioner with the digital flat panel imager to fall into the Flat Panel cradle. If the positioner is over a patient, there is a potential for injury. |
| Sep 10, 2009 | Not classified | Z-0121-2010 | Software design | A failed data transfer is possible that may result in data not being recorded in the interfaced system. Siemens Medical Solutions, Inc. USA became aware of this potential issue with its ARTISTE Linear Accelerator's Syngo RT Therapist v4.1… |
| 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. |
| Jul 30, 2009 | Not classified | Z-1064-2011 | Software design | Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters. |
| Apr 9, 2009 | Not classified | Z-1888-2009 | Software design | Unexpected treatment plan alteration-- Software issue may result in unintended modifications to treatment |
| Dec 20, 2008 | Not classified | Z-0949-2009 | Device Design | The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly. |
| Oct 23, 2008 | Not classified | Z-0857-2009 | Labeling design | Under certain conditions, the flat panel may move unexpectedly and collide with the patient. |
| Oct 23, 2008 | Not classified | Z-0927-2009 | Software design | If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption… |
| Jul 4, 2008 | Not classified | Z-0116-2009 | Software change control | Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images. |
The 5 latest of 24 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 15 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 29 ancestors have a recall of any class.
- Of its descendants, K082775 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K060226.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ARTISTE MV SAT M linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ARTISTE MV SATM includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngoTM RT Therapist Express Workspace with MVisionTM. The syngoTM RT Therapist Express Workspace is a software application that uses syngoTM based applications with these embedded features: • patient data…
Read the full statement (126 words)
The intended use of the ARTISTE MV SAT M linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
The ARTISTE MV SATM includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngoTM RT Therapist Express Workspace with MVisionTM.
The syngoTM RT Therapist Express Workspace is a software application that uses syngoTM based applications with these embedded features:
• patient data management, selection and setup by use of a local, on-board database,
• treatment delivery/verification and treatment recording by use of on-board applications,
• Megavoltage Cone Beam acquisition method for acquiring projection data for 3D reconstruction.
• Patient positioning verification by use of the OPTIVUE imaging system, including MVisionTM(Cone Beam acquisition and reconstruction and the Adaptive Targeting application).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072485 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072485: Artiste MV SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072485
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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