510(k) · Cleared
Recalled · Class II · 2020Artistetm Solution with Sys Vcio
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 Jun 27, 2012 as substantially equivalent to K103606 (Siemens Medical Solutions USA, Inc., 2011) and 3 other predicates after a 58-day review. Its family tree reaches back 13 generations to 1992. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 27, 2012
- Review
- 58 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 5
- Predicates
- 4
Its longest line of descent runs back 13 generations to K914698 (1992). 102 ancestors in all, the oldest K841997 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 9 generations between
- 3 generations backK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- 2 generations backK102671 Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010
- 1 generation backK103606 Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- This deviceK121295 Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK132935 Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace…Siemens Medical Solutions USA, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK142434 Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT…Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK182050 Linear Accelerator Control Console Software v13.1.010 Update, syngo…Siemens Medical Solutions USA, Inc. · 2018
Show all 13 generations
- Root · 13 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 12 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 11 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 10 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 9 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 8 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 7 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 6 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 4 generations backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- 2 generations backK102671 Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010
- 1 generation backK103606 Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- This deviceK121295 Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc. · 2014 · cites it directly2descendants
- K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc. · 2014 · cites it directly1descendant
- K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −12 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −11 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −10 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −9 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −8 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −6 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| −5 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| −4 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | 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 | — |
| −1 | K103606 | Artiste Solution with Sys_VB50 Update | Siemens Medical Solutions USA, Inc. | 2011 | 7 |
| 0 (this device) | K121295 | Artistetm Solution with Sys Vcio | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K132935 | Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +1 | K142434 | Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT… | Siemens Medical Solutions USA, Inc. | 2014 | 5 |
| +2 | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103606 | Artiste Solution with Sys_VB50 UpdateSummary page 2…4.3) and Control Console 13. The technological characteristics and fundamental technology of the ARTISTETM Solution remrain unchanged from the currently cleared device (K1 03606). The syn go® Software Architecture: The sYngoO Suite for Oncology Workspace clinically focused software utilizes the proprieta… | 2011 |
| * | K052315 | Simtec IM-Maxx 2 OptionSummary page 1…o®RTT Connect v4.2, v4,3, sYngo® Oncologist v4,3 syngo® Oncologist v4.2 SIMTEC IM MAXX 2 [(052315 /Sept. 22, AR'I'STETM1 Solution with the 2005 87_VCIO0… | 2005 |
| * | K072916 | Trilogy System with RapidarcSummary page 1…Therapist v4.3 flew feature Radiation Therapy (IMRT) rnARC Varian TrilogyTm System K(072916 / Nov. 9, 2007 ARTISTEITM Solution with the with RapidArc. SYSVCI 0 &… | 2007 |
| * | K052423 | Magnetom Systems with Syngo Expert - I OptionSummary page 2…mARC (also called rotational modulated arc thcrapy). IMRT) syngo® Expert I option on 1(052423 /Jan. 13, ARTISTE TM Solution with the MAGNETOM Systems 2006 SYSVClO & syng… | 2006 |
What descends from it? (3)
2 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, 2018 | Class II | Z-1401-2018 | 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. |
| May 29, 2013 | Class II | Z-1562-2013 | Device Design | The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView… |
| Jan 17, 2013 | Class II | Z-0907-2013 | Software design | Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 43 of the 102 ancestors have a recall of any class.
- Of its descendants, K132935 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K103606.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ARTISTETI, ONCORrM and PRI~hIlJSTMv family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The linear acceler-ator systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), moduilated arc therapy (mARC) and precision stereotactic radiation…
Read the full statement (196 words)
The intended use of the SIEMENS branded ARTISTETI, ONCORrM and PRI~hIlJSTMv family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The linear acceler-ator systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), moduilated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated.
The syngo® Suite for Oncologv Worksvaces:
The syngo® workspaces includes a number of syngo®& based, clinically focused advanced software applications that include patient data management, remote user communication within a local network, and the viewing, processing, manipulation, filming, and archiving of medical images.
The syngoO Wr'Therapist Workspace v4.3, contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo®DRT Therapist Workspace v4.3, can be interfaced with third party devices conforming to the DICOM Standard.
The syngo® RT Oncologist Workspace v4.3 permits localization, contouring, segmentation, image review and review and approval of treatment plan 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/K121295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121295: Artistetm Solution with Sys Vcio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121295
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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