510(k) · Cleared
Recalled · Class II · 2018CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM 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 Jul 1, 2015 after a 91-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 1, 2015
- Review
- 91 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK150873 CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM…Accuray Incorporated · 2015
- Descendant · cites it directly · 3 of its ownK171804 Zap-X Radiosurgery SystemZap Surgical Systems · 2017
- Descendant · 2 generations on · 2 of its ownK183698 Zap-X Radiosurgery SystemZap Surgical Systems · 2019
- Descendant · cites it directly · 2 of its ownK161136 Precision Treatment Planning SystemAccuray Incorporated · 2016
- Descendant · 3 generations on · 1 of its ownK211663 Zap-X Radiosurgical SystemZap Surgical Systems, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK171086 Accuray Precision Treatment Planning SystemAccuray Incorporated · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171804Zap-X Radiosurgery SystemZap Surgical Systems · 2017 · cites it directly3descendants
- K183698Zap-X Radiosurgery SystemZap Surgical Systems · 2019 · 2 generations on2descendants
- K161136Precision Treatment Planning SystemAccuray Incorporated · 2016 · cites it directly2descendants
- K211663Zap-X Radiosurgical SystemZap Surgical Systems, Inc. · 2021 · 3 generations on1descendant
- K171086Accuray Precision Treatment Planning SystemAccuray Incorporated · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System | Accuray Incorporated | 2015 | — |
| +1 | K171804 | Zap-X Radiosurgery System | Zap Surgical Systems | 2017 | — |
| +2 | K183698 | Zap-X Radiosurgery System | Zap Surgical Systems | 2019 | — |
| +1 | K161136 | Precision Treatment Planning System | Accuray Incorporated | 2016 | — |
| +3 | K211663 | Zap-X Radiosurgical System | Zap Surgical Systems, Inc. | 2021 | 2 |
| +2 | K171086 | Accuray Precision Treatment Planning System | Accuray Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | CyberKnife® M6™ System with InCise™ Multileaf Collimator Named without a submission number |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2018 | Class II | Z-0408-2019 | Process control | A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component. |
| Apr 10, 2018 | Class II | Z-1696-2019 | Other | There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171804 (Zap Surgical Systems, 2017) has gone furthest, with 3 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. 2015, 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® M6™ Systems 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/K150873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150873: CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150873
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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