510(k) · Cleared
ClearedXio Radiation Treatment Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Dec 2, 2003 as substantially equivalent to K971367 (Brainlab AG, 1997) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1997. 52 later devices descend from it.
- Decided
- Dec 2, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971367 (1997). 2 ancestors in all. 52 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK971367 Brainscan Conformal RT ModuleBrainlab AG · 1997
- This deviceK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
- Descendant · cites it directly · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 27 of its ownK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 4 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 5 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · cites it directly34descendants
- K102216Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · 2 generations on27descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 3 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 4 generations on17descendants
- K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971367 | Brainscan Conformal RT Module | Brainlab AG | 1997 | — |
| 0 (this device) | K032762 | Xio Radiation Treatment Planning System | Computerized Medical Systems, Inc. | 2003 | — |
| +1 | K092132 | Xio RTP System | Computerized Medical Systems, Inc. | 2009 | 12 |
| +2 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| +3 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +4 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| +5 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (2)
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.
What descends from it? (52)
See all 523 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and. in, hard-copy, either two- or three-dimensional. radiation dose distributions within a patient for a given treatment plan set-up.
Optionally, the user may elect to generate plans using Dynamic Conformal Arc Therapy capability. Dynamic Conformal Arc Therapy is a treatment modality in which the gantry rotates in an arc (or multiple arcs) over user-specified angles while the leaves of a multi-leaf collimator (MLC) continually reshape the beatn to conform to the target.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032762: Xio Radiation Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032762
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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