510(k) · Cleared
ClearedARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
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 Jun 15, 2022 as substantially equivalent to K173838 (Varian Medical Systems, Inc., 2018) and 1 other predicate after a 28-day review. Its family tree reaches back 15 generations to 2001.
- Decided
- Jun 15, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K010975 (2001). 25 ancestors in all, the oldest K952313 (1995). No later device cites it as a predicate yet.
- Root · 15 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 11 generations between
- 3 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- This deviceK221448 ARIA Radiation Therapy Management (v15.8), Eclipse Treatment…Varian Medical Systems, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 14 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 13 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 12 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 11 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 10 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 9 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 8 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 7 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 6 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 5 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 4 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 3 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- This deviceK221448 ARIA Radiation Therapy Management (v15.8), Eclipse Treatment…Varian Medical Systems, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −14 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −13 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −12 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −11 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −10 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −9 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −8 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −7 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −6 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −5 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −4 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −3 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −2 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −1 | K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018 | 1 |
| 0 (this device) | K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System… | Varian Medical Systems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K173838 | ARIA Radiation Therapy ManagementSummary page 4…ment Planning System Predicate device: ARIA Radiation Therapy Management, version Eclipse Treatment Planning System, version 15.6 15.5 (K173838) (K181145) No reference devices were used in this submission.… | 2018 |
| * | K181145 | Eclipse Treatment Planning SystemSummary page 4…A Radiation Therapy Management, version Eclipse Treatment Planning System, version 15.6 15.5 (K173838) (K181145) No reference devices were used in this submission.… | 2018 |
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 21 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 25 ancestors have a recall of any class.
- 4 other devices also cite its predicate K173838.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.…
Read the full statement (125 words)
The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
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/K221448 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221448: ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221448
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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