510(k) · Cleared
Recalled · Class II · 2022Aria Radiation Therapy Management
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 Apr 4, 2014 as substantially equivalent to K093527 (Varian Medical Systems, Inc., 2009) after a 135-day review. Its family tree reaches back 3 generations to 1995. 20 later devices descend from it. It has been recalled once.
- Decided
- Apr 4, 2014
- Review
- 135 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952313 (1995). 4 ancestors in all. 20 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
- 2 generations backK042956 VisionVarian Medical Systems, Inc. · 2005
- 1 generation backK093527 Aria Radiation Oncology with MirsVarian Medical Systems, Inc. · 2009 · Recalled
- This deviceK133572 Aria Radiation Therapy ManagementVarian Medical Systems, Inc. · 2014
- Descendant · cites it directly · 18 of its ownK173838 ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 9 of its ownK192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos…Varian Medical Systems, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK212294 Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK222941 Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK221408 ARIA Radiation Therapy Management (v16.1 MR3)Varian Medical Systems, Inc. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K173838ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. · 2018 · cites it directly18descendants
- K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc. · 2020 · 2 generations on9descendants
- K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc. · 2021 · 3 generations on4descendants
- K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. · 2023 · 3 generations on3descendants
- K221408ARIA Radiation Therapy Management (v16.1 MR3)Varian Medical Systems, Inc. · 2022 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | 1995 | — |
| −2 | K042956 | Vision | Varian Medical Systems, Inc. | 2005 | — |
| −1 | K093527 | Aria Radiation Oncology with Mirs | Varian Medical Systems, Inc. | 2009 | 9 |
| 0 (this device) | K133572 | Aria Radiation Therapy Management | Varian Medical Systems, Inc. | 2014 | — |
| +1 | K173838 | ARIA Radiation Therapy Management | Varian Medical Systems, Inc. | 2018 | 1 |
| +2 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy… | Varian Medical Systems, Inc. | 2020 | — |
| +3 | K212294 | Ethos Treatment Management, Ethos Treatment Planning | Varian Medical Systems, Inc. | 2021 | — |
| +3 | K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023 | — |
| +2 | K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | Varian Medical Systems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K093527 | Aria Radiation Oncology with MirsSummary page 1…tion therapy system 21 CER 892.5050, Class 11 Product Code: lYE Predicate Device: ARIA Radiation Oncology: K093527 Device Description: The ARIA Radiation Therapy Management product is a treatment plan and image… | 2009 |
What descends from it? (20)
See all 202 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 |
|---|---|---|---|---|
| Mar 21, 2022 | Class II | Z-0942-2022 | Software Design Change | Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K173838 (Varian Medical Systems, Inc., 2018) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K093527.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133572: Aria Radiation Therapy Management.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133572
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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