510(k) · Cleared
Recalled · 2011Varian Treatment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jul 12, 2010 as substantially equivalent to K050479 (Varian Medical Systems, 2005) after a 201-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 12, 2010
- Review
- 201 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001643 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005 · Recalled
- This deviceK093967 Varian TreatmentVarian Medical Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK151882 Varian Treatment (VTx)Varian Medical Systems, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151882Varian Treatment (VTx)Varian Medical Systems, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001643 | Varis 1.4G | Varian Medical Systems, Inc. | 2000 | 8 |
| −1 | K050479 | 4D Integrated Treatment Console | Varian Medical Systems | 2005 | 2 |
| 0 (this device) | K093967 | Varian Treatment | Varian Medical Systems, Inc. | 2010 | — |
| +1 | K151882 | Varian Treatment (VTx) | Varian Medical Systems, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K050479 | 4D Integrated Treatment ConsoleSummary page 1…tem 21 CFR 892.5050,iGIrMUJ Common/Usual Name: Varian Treatment Predicate Devices: Varian 4D Integrted Treatment Console, K050479 Device Description: Varian Treatment is a software device that performs an interface ro le to the Siemens, GE, and Elekt… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151882 | Varian Treatment (VTx) | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2011 | Not classified | Z-3105-2011 | Other | Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K151882 (Varian Medical Systems, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K050479.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Varian Treatment provides accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device from commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093967: Varian Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093967
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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