510(k) · Cleared
Recalled · 2010Varian C-Series Clinacs Clinac 600C,2100C,2500C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Assoc., Inc. · IYE Accelerator, Linear, Medical
Cleared on Feb 27, 1991 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 7 times.
- Decided
- Feb 27, 1991
- Review
- 156 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 7
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2010 | Not classified | Z-1249-2011 | Device Design | Position errors may result in misdelivery of radiation. |
| Jun 10, 2010 | Not classified | Z-0886-2011 | Other | The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch. |
| Apr 19, 2010 | Not classified | Z-1003-2011 | Labeling mix-ups | The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails. |
| May 29, 2009 | Not classified | Z-1729-2009 | Device Design | Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly. |
| Aug 11, 2008 | Not classified | Z-0117-2009 | Device Design | During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers. |
| Mar 30, 2005 | Not classified | Z-1530-05 | Device Design | Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated. |
| Feb 4, 2005 | Not classified | Z-0777-05 | Software design | Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K904364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904364: Varian C-Series Clinacs Clinac 600C,2100C,2500C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904364
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026