510(k) · Cleared
Recalled · Class II · 2012160MLC Option
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 18, 2009 as substantially equivalent to K072485 (Siemens Medical Solutions USA, Inc., 2007) and 2 other predicates after a 65-day review. Its family tree reaches back 10 generations to 1992. 4 later devices descend from it. It has been recalled 11 times.
- Decided
- Sep 18, 2009
- Review
- 65 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 10 generations to K914698 (1992). 46 ancestors in all, the oldest K862339 (1986). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 6 generations between
- 3 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- This deviceK092145 160MLC OptionSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK123812 Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity…Siemens Medical Solutions USA, Inc. · 2013 · 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
Show all 10 generations
- Root · 10 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 9 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 8 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 7 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 6 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 4 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 3 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- This deviceK092145 160MLC OptionSiemens Medical Solutions USA, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc. · 2013 · cites it directly3descendants
- 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 |
|---|---|---|---|---|---|
| −10 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −9 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −8 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −7 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −6 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −5 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −3 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| −2 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| −1 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K092145 | 160MLC Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K123812 | Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for… | Siemens Medical Solutions USA, Inc. | 2013 | 9 |
| +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 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072485 | Artiste MV SASummary page 1…lYE Substantial Equivalence Claimed To: PRODUCT Clearance Claim of Equivalence For: SIEMENS ARTISTE TM K072485 The Siemens branded Linear Accelerator with the 160 leaf MLC and the syn… | 2007 |
| * | K060226 | Oncor ExpressionSummary page 1…Workspaces including the syngo@ RT Therapist and RT Therapist Express. SIEMENS ONCOR TM K060226 ONCOR TM linear accelerator families and COHERENCE Expression Workspaces (or the re… | 2006 |
| * | K082775 | Prescision OptionSummary page 1…technology marketed as MVisionTm and Adaptive TargetingTM. SIEMENS PreScision TM K082775 Establishes the basic hardware/firmware and software Option components across a… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123812 | Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens… | 2013 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2012 | Not classified | Z-1493-2012 | Labeling design | Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally, there… |
| Apr 15, 2011 | Not classified | Z-2404-2011 | Other | Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment. |
| 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 11 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 17 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 20 of the 46 ancestors have a recall of any class.
- Of its descendants, K123812 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K072485.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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. The linear accelerator is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation…
Read the full statement (216 words)
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.
The linear accelerator is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treatments, fractionated intensity modulated radiation therapy (IMRT) for lesions, tumors and conditions anywhere in the body where radiation therapy is indicated.
Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multi-leaf collimator that is marketed as 160MLC. The 160MLC 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 for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485).
The syngo®Suite for Oncology Workspaces includes a number of syngo based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092145: 160MLC Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092145
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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