510(k) · Cleared
ClearedPrescision 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 Feb 19, 2009 as substantially equivalent to K072485 (Siemens Medical Solutions USA, Inc., 2007) and 5 other predicates after a 150-day review. Its family tree reaches back 9 generations to 1992. 9 later devices descend from it.
- Decided
- Feb 19, 2009
- Review
- 150 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K914698 (1992). 45 ancestors in all, the oldest K862339 (1986). 9 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 5 generations between
- 3 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK082775 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 · 2 generations on · 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
- Descendant · 2 generations on · 3 of its ownK123812 Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity…Siemens Medical Solutions USA, Inc. · 2013 · Recalled
Show all 9 generations
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 8 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 7 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 6 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 5 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 3 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · cites it directly7descendants
- K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc. · 2010 · 2 generations on5descendants
- K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc. · 2011 · cites it directly4descendants
- K092145160MLC OptionSiemens Medical Solutions USA, Inc. · 2009 · cites it directly4descendants
- K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc. · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −8 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −7 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −6 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −5 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −4 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −2 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| −1 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| 0 (this device) | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | 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 |
| +1 | K092145 | 160MLC Option | Siemens Medical Solutions USA, Inc. | 2009 | 11 |
| +2 | K123812 | Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for… | Siemens Medical Solutions USA, Inc. | 2013 | 9 |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 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? (6)
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…roduct Code: lYE Substantial Equivalence Claimed To: PRODUCT Clearance Claim of Equivalence For: SIEMENS ARTISTETM K072485 The Stereo mode with the 160 MLC SIEMENS ONCORTM K060226 ONCORTM and PRIMUSTM linear accelerator famil… | 2007 |
| * | K060226 | Oncor ExpressionSummary page 1…Clearance Claim of Equivalence For: SIEMENS ARTISTETM K072485 The Stereo mode with the 160 MLC SIEMENS ONCORTM K060226 ONCORTM and PRIMUSTM linear accelerator families Expression with Stereo Mode and COHERENC… | 2006 |
| * | K993425 | PrimusSummary page 1…e-branded syngoO Suite for Oncology Workspaces) and the 82 leaf MLC marketed as OPTIFOCUS. SIEMENS PRIMUSTM K993425 PRIMUSTM family of linear accelerators with the Stereo Mode, PRIMEVIEW 3i syst… | 1999 |
| * | K061140 | Trilogy Radiotherapy Delivery SystemSummary page 1…M family of linear accelerators with the Stereo Mode, PRIMEVIEW 3i system, the 58 leaf MLC Varian TrilogyTM K061140 Steretotactic (SRT) and Stereotactic Radio-Surgery (SRS) RadiationTherapy with… | 2006 |
| * | K060912 | Modification to: HI-Art SystemSummary page 1…tactic (SRT) and Stereotactic Radio-Surgery (SRS) RadiationTherapy withhighdosebeam 'rate. TomoTherapy Hi-ArtTM K060912 Steretotactic (SRT) and Stereotactic Radio-Surgery (SRS) with unflattened beam… | 2006 |
| * | K052325 | Cyberknife System for Stereotactic Radiosurgery/RadiotherapySummary page 1…ttened beam delivery and extended treatment field for Stereotactic Body Radiatiofi Theraly.i Accuray CyberknifeTM K052325 Steretotactic (SRT) and Stereotactic Radio-Surgery (SRS) robotic delivery sy… | 2005 |
What descends from it? (9)
3 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)
No FDA recall names this device.
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 45 ancestors have a recall of any class.
- Of its descendants, K090683 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 7 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 TM, ONCOR™ and PRIMUS TM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The LINAC 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 the PreScision™ option, supports precision stereotactic…
Read the full statement (140 words)
The intended use of the SIEMENS branded ARTISTE TM, ONCOR™ and PRIMUS TM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
The LINAC 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 the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, tumors and conditions anywhere in the body where radiation therapy is indicated.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082775 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082775: Prescision Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082775
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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