510(k) · Cleared
Recalled · 2009Motion Tracking
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuray, Inc. · IYE Accelerator, Linear, Medical
Cleared on Apr 22, 2002 as substantially equivalent to K011024 (Accuray, Inc., 2001) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1987. It has been recalled 2 times.
- Decided
- Apr 22, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864886 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −1 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K020294 | Motion Tracking | Accuray, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K011024 | Cyberknife SystemSummary page 1…le, CA 94085 Corresponding Official: Donald E. Caddes Title: President and COO Telephone: 408-522-3740 Fax: 408-522-3749 Predicate Devices: Accuray CyberKnife® System, K011024 and Varian Medical Systems RPM Respiratory Gating System, K983629. Device Description: Presently, irradiation of lesions that mo… | 2001 |
| * | K983629 | RPM Respiratory Gating SystemSummary page 1…sident and COO Telephone: 408-522-3740 Fax: 408-522-3749 Predicate Devices: Accuray CyberKnife® System, K011024 and Varian Medical Systems RPM Respiratory Gating System, K983629. Device Description: Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the… | 1999 |
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 |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
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 | — |
What is it indicated for?
To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020294: Motion Tracking.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020294
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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