510(k) · Cleared
Recalled · Class II · 2015Aria Radiation Oncology with Mirs
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 Dec 15, 2009 as substantially equivalent to K042956 (Varian Medical Systems, Inc., 2005) after a 29-day review. Its family tree reaches back 2 generations to 1995. 29 later devices descend from it. It has been recalled 9 times.
- Decided
- Dec 15, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952313 (1995). 3 ancestors in all. 29 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
- 1 generation backK042956 VisionVarian Medical Systems, Inc. · 2005
- This deviceK093527 Aria Radiation Oncology with MirsVarian Medical Systems, Inc. · 2009
- Descendant · cites it directly · 20 of its ownK133572 Aria Radiation Therapy ManagementVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 18 of its ownK173838 ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 9 of its ownK192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos…Varian Medical Systems, Inc. · 2020
- Descendant · cites it directly · 8 of its ownK120067 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K133572Aria Radiation Therapy ManagementVarian Medical Systems, Inc. · 2014 · cites it directly20descendants
- K173838ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. · 2018 · 2 generations on18descendants
- K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc. · 2020 · 3 generations on9descendants
- K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · cites it directly8descendants
- K142142Quality ReportsSun Nuclear Corporation · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | 1995 | — |
| −1 | K042956 | Vision | Varian Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K093527 | Aria Radiation Oncology with Mirs | Varian Medical Systems, Inc. | 2009 | — |
| +1 | K133572 | Aria Radiation Therapy Management | Varian Medical Systems, Inc. | 2014 | 1 |
| +2 | K173838 | ARIA Radiation Therapy Management | Varian Medical Systems, Inc. | 2018 | 1 |
| +3 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy… | Varian Medical Systems, Inc. | 2020 | — |
| +1 | K120067 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 3 |
| +2 | K142142 | Quality Reports | Sun Nuclear Corporation | 2014 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K042956 | VisionSummary page 1…fined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling. ARIA Radiation Oncology (K042956) has been modified to introduce a new component called MIRS (Multimodality Image Registration and Segmentation). MIRS provides co… | 2005 |
| † | K062391 | Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02… | 2006 |
| † | K051076 | Zoll Stat*Padz MWP Multi-Function Electrodes | 2005 |
| † | K083591 | Ikoengelo, Version 2 | 2008 |
What descends from it? (29)
See all 293 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 |
|---|---|---|---|---|
| Sep 28, 2015 | Class II | Z-0170-2016 | Software design (manufacturing process) | An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. |
| Nov 18, 2013 | Class II | Z-0552-2014 | Software design | An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change. |
| Nov 5, 2012 | Class II | Z-0531-2013 | Software design | Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or… |
| Sep 24, 2012 | Class II | Z-0187-2013 | Software design | An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued. |
| Jul 2, 2012 | Class II | Z-2153-2012 | Software design | A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported. |
| Dec 16, 2011 | Not classified | Z-0713-2012 | Under Investigation by firm | Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No.… |
| May 17, 2011 | Not classified | Z-2763-2011 | Software design | An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open… |
| Mar 9, 2011 | Not classified | Z-2125-2011 | Software design | An issue was identified with the gantry rotation direction when creating opposing field within the RT Chart function of ARIA, or possibly with third party planning systems and delivering the plan at 4DITC. |
| Feb 18, 2011 | Not classified | Z-1905-2011 | Other | An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K133572 (Varian Medical Systems, Inc., 2014) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K042956.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Oncology 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 Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
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/K093527 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093527: Aria Radiation Oncology with Mirs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093527
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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