510(k) · Cleared
Recalled · 2011Cyberknife 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 Nov 17, 2010 after a 64-day review. The FDA summary names its predicate without a number. 32 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 17, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK102650 Cyberknife Robotic Radiosurgery SystemAccuray Incorporated · 2010
- Descendant · cites it directly · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 25 of its ownK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 23 of its ownK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- Descendant · 4 generations on · 15 of its ownK170817 HalcyonVarian Medical Systems, Inc. · 2017
- Descendant · 5 generations on · 14 of its ownK181032 HalcyonVarian Medical Systems, Inc. · 2018
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · cites it directly31descendants
- K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · 2 generations on25descendants
- K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017 · 3 generations on23descendants
- K170817HalcyonVarian Medical Systems, Inc. · 2017 · 4 generations on15descendants
- K181032HalcyonVarian Medical Systems, Inc. · 2018 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102650 | Cyberknife Robotic Radiosurgery System | Accuray Incorporated | 2010 | — |
| +1 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| +2 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| +3 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| +4 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
| +5 | K181032 | Halcyon | Varian Medical Systems, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | CyberKnife System Named without a submission number |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140528 | True Beam, True Beam STX, Edge | 2014 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2011 | Not classified | Z-0035-2012 | Process control | A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly. |
| Sep 12, 2011 | Not classified | Z-0036-2012 | Process control | A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140528 (Varian Medical Systems, Inc., 2014) has gone furthest, with 31 descendants of its own.
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?
The CyberKnife® Robotic Radiosurgery System and CyberKnife VSI~ Robotic Radiosurgery System are 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/K102650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102650: Cyberknife Robotic Radiosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102650
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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