510(k) · Cleared
Recalled · 2009Cyberknife Robotic Radiosurgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuray Incorporated · IYE Accelerator, Linear, Medical
Cleared on Sep 21, 2007 after a 15-day review. The FDA summary names no predicate by number. It has been recalled 7 times.
- Decided
- Sep 21, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 7
- Predicates
- 0
The FDA summary names no predicate by number.
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.
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What was it cleared against?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|---|
| Jul 21, 2009 | Not classified | Z-0853-2011 | Device Design | Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches. |
| Jun 22, 2009 | Not classified | Z-1810-2009 | Software design | Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area. |
| Mar 16, 2009 | Not classified | Z-0909-2011 | Device Design | The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in… |
| Mar 16, 2009 | Not classified | Z-0908-2011 | Device Design | The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in… |
| Nov 14, 2008 | Not classified | Z-0629-2009 | Software design | System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury. |
| May 1, 2008 | Not classified | Z-1862-2008 | Software design | Couch may move unexpectedly, which may result in patient impacting the linear accelerator. |
| Apr 9, 2008 | Not classified | Z-2056-2008 | Software design | Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users. |
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. 2007, 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 CyberKnife® Robotic Radiosurgery System is indicated for treatment
planning and image guided stereotactic radiosurgery and precision radiotherapy
for lesions, tumors and conditions anywhere in the body when radiation treatment
is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072504 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072504: Cyberknife Robotic Radiosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072504
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026