# K093527: Aria Radiation Oncology with Mirs

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 15, 2009 after 29 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952313 (1995). 3 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042956: Vision, Varian Medical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K133572: Aria Radiation Therapy Management (2014), 20 descendants of its own
- K173838: ARIA Radiation Therapy Management (2018), 18 descendants of its own
- K192377: Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon (2020), 9 descendants of its own
- K120067: Mosaiq Oncology Information System (2012), 8 descendants of its own
- K142142: Quality Reports (2014), 5 descendants of its own

## Recalls of this device
- Sep 28, 2015 · Class II · Z-0170-2016: 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: 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 Moni
- Nov 5, 2012 · Class II · Z-0531-2013: 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 st
- Sep 24, 2012 · Class II · Z-0187-2013: 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: 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: 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 
- May 17, 2011 · Not classified · Z-2763-2011: 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 c
- Mar 9, 2011 · Not classified · Z-2125-2011: 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 4
- Feb 18, 2011 · Not classified · Z-1905-2011: 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 result

## Indications for use
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.

Source page: https://510kreport.com/device/K093527
Methodology: https://510kreport.com/methodology