510(k) · Cleared
Recalled · Class II · 2026CyberKnife Treatment Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuray Incorportaed · IYE Accelerator, Linear, Medical
Cleared on Apr 11, 2017 as substantially equivalent to K150873 (Accuray Incorporated, 2015) after a 26-day review. Its family tree reaches back 1 generation to 2015. It has been recalled 4 times.
- Decided
- Apr 11, 2017
- Review
- 26 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K150873 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backK150873 CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM…Accuray Incorporated · 2015 · Recalled
- This deviceK170788 CyberKnife Treatment Delivery SystemAccuray Incorportaed · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System | Accuray Incorporated | 2015 | 2 |
| 0 (this device) | K170788 | CyberKnife Treatment Delivery System | Accuray Incorportaed | 2017 | — |
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 |
|---|---|---|---|
| * | K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemSummary page 5…valence The CyberKnife® Treatment Delivery System is substantially equivalent to the treatment delivery component of the predicate, CyberKnife M6 Systems (cleared under K150873). The intended use for radiologic applications, principles of operation, technological characteristics are the same as the treatm… | 2015 |
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 16, 2026 | Class II | Z-2640-2026 | Software design | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the… |
| Jun 16, 2026 | Class II | Z-2644-2026 | Software design | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the… |
| Dec 23, 2024 | Class II | Z-1023-2025 | Component design/selection | Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged. |
| Feb 26, 2021 | Class II | Z-1272-2021 | Equipment maintenance | The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K150873.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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® Treatment Delivery System is indicated for 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/K170788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170788: CyberKnife Treatment Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170788
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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