510(k) · Cleared
ClearedARIA Radiation Therapy Management (v16.1 MR3)
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 17, 2022 as substantially equivalent to K173838 (Varian Medical Systems, Inc., 2018) after a 32-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 17, 2022
- Review
- 32 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K952313 (1995). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
- 4 generations backK042956 VisionVarian Medical Systems, Inc. · 2005
- 3 generations backK093527 Aria Radiation Oncology with MirsVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK133572 Aria Radiation Therapy ManagementVarian Medical Systems, Inc. · 2014 · Recalled
- 1 generation backK173838 ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. · 2018 · Recalled
- This deviceK221408 ARIA Radiation Therapy Management (v16.1 MR3)Varian Medical Systems, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK230699 ARIA Radiation Therapy Management (v18.0)Varian Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK242463 ARIA Radiation Therapy Management System (18.1)Varian Medical Systems, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK260733 MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See all- K230699ARIA Radiation Therapy Management (v18.0)Varian Medical Systems, Inc. · 2023 · cites it directly2descendants
- K242463ARIA Radiation Therapy Management System (18.1)Varian Medical Systems, Inc. · 2024 · 2 generations on1descendant
- K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | 1995 | — |
| −4 | K042956 | Vision | Varian Medical Systems, Inc. | 2005 | — |
| −3 | K093527 | Aria Radiation Oncology with Mirs | Varian Medical Systems, Inc. | 2009 | 9 |
| −2 | K133572 | Aria Radiation Therapy Management | Varian Medical Systems, Inc. | 2014 | 1 |
| −1 | K173838 | ARIA Radiation Therapy Management | Varian Medical Systems, Inc. | 2018 | 1 |
| 0 (this device) | K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | Varian Medical Systems, Inc. | 2022 | — |
| +1 | K230699 | ARIA Radiation Therapy Management (v18.0) | Varian Medical Systems, Inc. | 2023 | — |
| +2 | K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024 | — |
| +3 | K260733 | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K173838 | ARIA Radiation Therapy ManagementSummary page 4…latory class: Class II Product code: IYE III. PREDICATE DEVICE Predicate Device: ARIA Radiation Therapy Management, version 15.5 (K173838) No reference devices were used in this submission. IV. DEVICE DESCRIPTION The ARIA Radia… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230699 | ARIA Radiation Therapy Management (v18.0) | 2023 | 2 |
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 27 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K230699 (Varian Medical Systems, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 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.
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/K221408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221408: ARIA Radiation Therapy Management (v16.1 MR3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221408
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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