510(k) · Cleared
ClearedMRIA Radiation Therapy Information System (MRIA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manteia Technologies Co., Ltd. · IYE Accelerator, Linear, Medical
Cleared on Aug 26, 2026 as substantially equivalent to K242463 (Varian Medical Systems, Inc., 2024) after a 173-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Aug 26, 2026
- Review
- 173 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K952313 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
- 7 generations backK042956 VisionVarian Medical Systems, Inc. · 2005
- 6 generations backK093527 Aria Radiation Oncology with MirsVarian Medical Systems, Inc. · 2009 · Recalled
- 5 generations backK133572 Aria Radiation Therapy ManagementVarian Medical Systems, Inc. · 2014 · Recalled
- 4 generations backK173838 ARIA Radiation Therapy ManagementVarian Medical Systems, Inc. · 2018 · Recalled
- 3 generations backK221408 ARIA Radiation Therapy Management (v16.1 MR3)Varian Medical Systems, Inc. · 2022
- 2 generations backK230699 ARIA Radiation Therapy Management (v18.0)Varian Medical Systems, Inc. · 2023
- 1 generation backK242463 ARIA Radiation Therapy Management System (18.1)Varian Medical Systems, Inc. · 2024
- This deviceK260733 MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | 1995 | — |
| −7 | K042956 | Vision | Varian Medical Systems, Inc. | 2005 | — |
| −6 | K093527 | Aria Radiation Oncology with Mirs | Varian Medical Systems, Inc. | 2009 | 9 |
| −5 | K133572 | Aria Radiation Therapy Management | Varian Medical Systems, Inc. | 2014 | 1 |
| −4 | K173838 | ARIA Radiation Therapy Management | Varian Medical Systems, Inc. | 2018 | 1 |
| −3 | K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | Varian Medical Systems, Inc. | 2022 | — |
| −2 | K230699 | ARIA Radiation Therapy Management (v18.0) | Varian Medical Systems, Inc. | 2023 | — |
| −1 | K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K242463 | ARIA Radiation Therapy Management System (18.1)Summary page 5…II Product Code: IYE Regulation Number: 21CFR 892.5050 Review Panel: Radiology III. PREDICATE DEVICE Predicate Device: ARIA Radiation Therapy Management System (18.1) (K242463) Reference Device: MOSAIQ Oncology Information System (K183034) IV. DEVICE DESCRIPTION MRIA, defined as a radiation therapy info… | 2024 |
| † | K183034 | MOSAIQ Oncology Information System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 9 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
MRIA is a radiation therapy information system, mainly for doctors, physicists, technologists and administrators in the radiotherapy department of hospitals to solve the problem of inconvenient information interaction in their positioning, contouring, planning and treatment sessions.
MRIA is not a treatment planning system or a radiation delivery device. It is used only for process progress management and treatment information management for radiotherapy patients.
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/K260733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260733: MRIA Radiation Therapy Information System (MRIA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260733
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026