510(k) · Cleared
ClearedHalcyon, Ethos Radiotherapy System (5.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Aug 3, 2026 as substantially equivalent to K252977 (Varian Medical Systems, Inc., 2026) after a 60-day review. Its family tree reaches back 19 generations to 2001.
- Decided
- Aug 3, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K010975 (2001). 65 ancestors in all, the oldest K864886 (1987). No later device cites it as a predicate yet.
- Root · 19 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 15 generations between
- 3 generations backK222941 Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023
- 2 generations backK232113 Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023
- 1 generation backK252977 Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
- This deviceK261856 Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 18 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 17 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 16 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 15 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 14 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 13 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 12 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 11 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 10 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 9 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 8 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 7 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 6 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 5 generations backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- 4 generations backK192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos…Varian Medical Systems, Inc. · 2020
- 3 generations backK222941 Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023
- 2 generations backK232113 Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023
- 1 generation backK252977 Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
- This deviceK261856 Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −18 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −17 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −16 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −15 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −14 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −13 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −12 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −11 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −10 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −9 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −8 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −7 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −6 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −5 | K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018 | 1 |
| −4 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy… | Varian Medical Systems, Inc. | 2020 | — |
| −3 | K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023 | — |
| −2 | K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023 | — |
| −1 | K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026 | — |
| 0 (this device) | K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K252977 | Halcyon, Ethos Radiotherapy System (5.0)Summary page 5…stem IYE | 21 CFR 892.5050 | Class II PREDICATE DEVICE Predicate Device Name: Halcyon, Ethos Radiotherapy System (K252977) Reference Device(s): No reference devices were used in this submission. DEVICE DESCRIPTION Halcyon and Eth… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 40 of the 65 ancestors have 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. 2026, 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?
Halcyon and Ethos radiotherapy system are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated for adults and pediatric patients. Halcyon and Ethos radiotherapy system with the HyperSight imaging feature produce kV CBCT anatomical images that can be used in the simulation and planning of radiation therapy. The Halcyon and Ethos Radiotherapy…
Read the full statement (121 words)
Halcyon and Ethos radiotherapy system are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
Halcyon and Ethos radiotherapy system with the HyperSight imaging feature produce kV CBCT anatomical images that can be used in the simulation and planning of radiation therapy.
The Halcyon and Ethos Radiotherapy systems may be used in the delivery of radiation treatment for adults with the following non-cancerous medically refractory hyperproliferative disorders: Dupuytren's contracture, Ledderhose disease, heterotopic ossification, and keloids; and low dose radiotherapy for adults with non-cancerous medically refractory osteoarthritis; and the following periarticular soft tissue disorders: plantar fasciitis, shoulder syndrome, trochanteric bursitis, and tennis/golf elbow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261856: Halcyon, Ethos Radiotherapy System (5.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261856
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026