510(k) · Cleared
Recalled · Class II · 2020Artiste Solution with Sys_VB50 Update
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 Apr 15, 2011 as substantially equivalent to K102671 (Siemens Medical Solutions USA, Inc., 2010) and 4 other predicates after a 127-day review. Its family tree reaches back 12 generations to 1992. 4 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 15, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 7
- Predicates
- 5
Its longest line of descent runs back 12 generations to K914698 (1992). 88 ancestors in all, the oldest K841997 (1984). 4 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 8 generations between
- 3 generations backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- 1 generation backK102671 Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010
- This deviceK103606 Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK121295 Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 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 · 2 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 · 3 generations on · 0 of its ownK182050 Linear Accelerator Control Console Software v13.1.010 Update, syngo…Siemens Medical Solutions USA, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 11 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 10 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 9 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 8 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 7 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 6 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 5 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 3 generations backK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
- 1 generation backK102671 Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010
- This deviceK103606 Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012 · cites it directly3descendants
- 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 · 2 generations on1descendant
- K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −11 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −10 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −9 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −8 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −7 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −5 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| −4 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| −3 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | 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 | — |
| 0 (this device) | K103606 | Artiste Solution with Sys_VB50 Update | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | K121295 | Artistetm Solution with Sys Vcio | Siemens Medical Solutions USA, Inc. | 2012 | 5 |
| +1 | K132935 | Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +2 | K142434 | Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT… | Siemens Medical Solutions USA, Inc. | 2014 | 5 |
| +3 | 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 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (5)
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 |
|---|---|---|---|
| * | K102671 | Syngo RT Therapist Connect Workspace, V4.2Summary page 1…ion: 892.5050 Product Code: IYE Substantial Equivalence Claimed To: %~ syngo®& RT Therapist K102671 /syngb® RT Therapist Connect v4.2 software update Connect for RT Oct. 12, SYS_-VB50 and Control Console 12, an… | 2010 |
| * | K072485 | Artiste MV SASummary page 1…4.2 2010 licensed features,-In-Line kVieWTM and Multiple including Control XTM . Console 12. ART1STETM Solution K072485/I ARTISTETM Solution with the syngo®)RT Therapist (aka ARTISTE MV) Dec. 27, Connect v4.2 with software upda… | 2007 |
| * | K060633 | Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0Summary page 5…features in the Dosimetrist v2.7 (KIOI 1119) *Image and plan review and approval and Adaptive Targeting in the Oncologist v2.O (K060633) Summary: In sumnmary, it is SIEMENS' belief that the ARTISTE with the Sys VB50 update does not introduce any new potential saf… | 2006 |
| * | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864Summary page 2…May 01, Targeting and 3D) portai image approval. Adaptive Targeting and 2006 2D portal image approval. syngo®)Dosimetrist K101119/ syngo®&RT Oncologist v4.2 with Basic, Advance Workspace v2.7 June 16, and Model based Segmentatio… | 2010 |
| * | K082775 | Prescision OptionSummary page 5…Therapist Assist workspaces, electron cone accessories and a collision avoidance system, *and to the stereotactic option FreScision (K082775) for high dose rate, unflat energies, *additionally to the Advanced Segmentation and Model ba… | 2009 |
What descends from it? (4)
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. |
| Jul 26, 2016 | Class II | Z-2876-2016 | Software design | Software patch installation to address several safety issues. |
| 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. |
| Apr 4, 2013 | Class II | Z-1182-2013 | Software design | Software update to fix multiple safety related issues. |
| Jun 25, 2012 | Class II | Z-2073-2012 | Software design | Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again… |
| 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. |
| Nov 2, 2011 | Not classified | Z-0462-2012 | Software design | The software release will bring current Installed Base system to the forward production version. It is a result of the final system testing addressing several safety issues that are not critical for the safe use of the device and multiple… |
The 5 latest of 7 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 19 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 33 of the 88 ancestors have a recall of any class.
- Of its descendants, K121295 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and precision stereotactic applications. The stereotactic applications may…
Read the full statement (217 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 systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and precision stereotactic applications. The stereotactic applications may include single-session radiosurgery, fractionated stereotactic radiation therapy, or fractionated stereotactic intensity modulated radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated.
The syngo® Suite for Oncology Workspaces:
The syngo® 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.
The syngo® RT Therapist Connect Workspace v4.2, contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace v4.2, can be interfaced with third party devices conforming to the DICOM Standard.
The syngo® RT Oncologist Workspace permits localization, contouring, segmentation, image calibration, and review 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/K103606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103606: Artiste Solution with Sys_VB50 Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103606
Report an extraction error
Are you the manufacturer?
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