510(k) · Cleared
ClearedARIA Radiation Therapy Management System (18.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Dec 13, 2024 as substantially equivalent to K230699 (Varian Medical Systems, Inc., 2023) after a 116-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Dec 13, 2024
- Review
- 116 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K952313 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
- 6 generations backK042956 VisionVarian Medical Systems, Inc. · 2005
- 5 generations backK093527 Aria Radiation Oncology with MirsVarian Medical Systems, Inc. · 2009 · Recalled
- 4 generations backK133572 Aria Radiation Therapy ManagementVarian Medical Systems, Inc. · 2014 · Recalled
- 3 generations backK173838 ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. · 2018 · Recalled
- 2 generations backK221408 ARIA Radiation Therapy Management (v16.1 MR3)Varian Medical Systems, Inc. · 2022
- 1 generation backK230699 ARIA Radiation Therapy Management (v18.0)Varian Medical Systems, Inc. · 2023
- This deviceK242463 ARIA Radiation Therapy Management System (18.1)Varian Medical Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260733 MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | 1995 | — |
| −6 | K042956 | Vision | Varian Medical Systems, Inc. | 2005 | — |
| −5 | K093527 | Aria Radiation Oncology with Mirs | Varian Medical Systems, Inc. | 2009 | 9 |
| −4 | K133572 | Aria Radiation Therapy Management | Varian Medical Systems, Inc. | 2014 | 1 |
| −3 | K173838 | ARIA Radiation Therapy Management | Varian Medical Systems, Inc. | 2018 | 1 |
| −2 | 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 | — |
| 0 (this device) | K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K230699 | ARIA Radiation Therapy Management (v18.0)Summary page 5…nagement System v18.1 Legally Marketed Equivalent Device (Predicate) Product: ARIA Radiation Therapy Management System v18.0 510(k) Number: K230699 Intended Use: The ARIA Radiation Therapy Management product is a treatment plan and image m… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260733 | MRIA Radiation Therapy Information System (MRIA) | 2026 | 0 |
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 29 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K260733 (Manteia Technologies Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
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/K242463 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242463: ARIA Radiation Therapy Management System (18.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242463
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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