510(k) · Cleared
ClearedHalcyon
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 May 9, 2018 as substantially equivalent to K170817 (Varian Medical Systems, Inc., 2017) after a 21-day review. Its family tree reaches back 12 generations to 1995. 14 later devices descend from it.
- Decided
- May 9, 2018
- Review
- 21 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K926449 (1995). 36 ancestors in all, the oldest K864886 (1987). 14 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 8 generations between
- 3 generations backK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 2 generations backK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- 1 generation backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- This deviceK181032 HalcyonVarian Medical Systems, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos…Varian Medical Systems, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK212294 Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK222941 Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK232479 ART-PlanTherapanacea · 2023
- Descendant · 3 generations on · 2 of its ownK232113 Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 11 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 10 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 9 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 8 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 7 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 6 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 5 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 4 generations backK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 3 generations backK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 2 generations backK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- 1 generation backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- This deviceK181032 HalcyonVarian Medical Systems, Inc. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc. · 2020 · cites it directly9descendants
- K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc. · 2021 · 2 generations on4descendants
- K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023 · 2 generations on3descendants
- K232479ART-PlanTherapanacea · 2023 · 3 generations on2descendants
- K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −11 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −10 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −9 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −8 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −7 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −6 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −5 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −4 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| −3 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| −2 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| −1 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
| 0 (this device) | K181032 | Halcyon | Varian Medical Systems, Inc. | 2018 | — |
| +1 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy… | Varian Medical Systems, Inc. | 2020 | — |
| +2 | K212294 | Ethos Treatment Management, Ethos Treatment Planning | Varian Medical Systems, Inc. | 2021 | — |
| +2 | K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023 | — |
| +3 | K232479 | ART-Plan | Therapanacea | 2023 | — |
| +3 | K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K170817 | HalcyonSummary page 4…21CFR892.5050, IYE, Class II Common/Usual Name: Medical Linear Accelerator Predicate Devices: Halcyon (K170817) Device Description: Halcyon is a single energy medical linac designed to deliver Image Guided… | 2017 |
What descends from it? (14)
See all 143 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)
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 23 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 26 of the 36 ancestors have a recall of any class.
- Of its descendants, K192377 (Varian Medical Systems, Inc., 2020) has gone furthest, with 9 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. 2018, 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 is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181032: Halcyon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181032
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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