510(k) · Cleared
Recalled · 2010Xio RTP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 24, 2009 as substantially equivalent to K032762 (Computerized Medical Systems, Inc., 2003) and 2 other predicates after a 71-day review. Its family tree reaches back 5 generations to 2001. 34 later devices descend from it. It has been recalled 12 times.
- Decided
- Sep 24, 2009
- Review
- 71 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 12
- Predicates
- 3
Its longest line of descent runs back 5 generations to K010975 (2001). 23 ancestors in all, the oldest K862643 (1987). 34 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 3 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 2 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 1 generation backK071760 Modification to: Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007
- This deviceK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009
- Descendant · cites it directly · 27 of its ownK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 3 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 4 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- Descendant · 5 generations on · 15 of its ownK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K102216Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · cites it directly27descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 2 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 3 generations on17descendants
- K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 4 generations on16descendants
- K170355RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −4 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −3 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −2 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −1 | K071760 | Modification to: Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | — |
| 0 (this device) | K092132 | Xio RTP System | Computerized Medical Systems, Inc. | 2009 | — |
| +1 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| +2 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +3 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| +4 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| +5 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K032762 | Xio Radiation Treatment Planning SystemSummary page 2…XiO is substantially equivalent to these products in intended use and safety and effectiveness. 1. XiO RTP System Computerized Medical Systems, Inc. K032762 2. Eclipse Treatment Planning System Varian Medical Systems K071760 3. Oncentra Masterplan Nucletron Co… | 2003 |
| * | K071760 | Modification to: Eclipse Treatment Planning SystemSummary page 2…fectiveness. 1. XiO RTP System Computerized Medical Systems, Inc. K032762 2. Eclipse Treatment Planning System Varian Medical Systems K071760 3. Oncentra Masterplan Nucletron Corporation K081281 XIO INTENDED USE The XiO RTP System is used to create trea… | 2007 |
| * | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy)Summary page 2…ems, Inc. K032762 2. Eclipse Treatment Planning System Varian Medical Systems K071760 3. Oncentra Masterplan Nucletron Corporation K081281 XIO INTENDED USE The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation t… | 2008 |
What descends from it? (34)
See all 342 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 |
|---|---|---|---|---|
| Oct 3, 2010 | Not classified | Z-2579-2011 | Software design | XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no… |
| Sep 10, 2010 | Not classified | Z-2408-2011 | Software design | When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate. |
| May 28, 2010 | Not classified | Z-2595-2011 | Software design | XiO Software: when Digitally Reconstructed Radiographs (DRRs) are generated in XiO, and DICOM is used to export the DRRs (File-Print-DRR), the exported images are associated with the Beams, but NOT the Plan. The Plan association had… |
| May 27, 2010 | Not classified | Z-2593-2011 | Software design | XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a… |
| May 27, 2010 | Not classified | Z-2407-2011 | Software design | XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO. |
| May 19, 2010 | Not classified | Z-2604-2011 | Software design | XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam.… |
| Apr 15, 2010 | Not classified | Z-1655-2010 | Software design | Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening |
| Feb 22, 2010 | Not classified | Z-1209-2010 | Software design | Inconsistent MLC positions, dose, and monitor units |
| May 13, 2009 | Not classified | Z-2568-2011 | Software design | In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is… |
| Dec 9, 2008 | Not classified | Z-2567-2011 | Software design | XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking… |
| May 14, 2008 | Not classified | Z-2574-2011 | Software design | In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight. |
| Apr 8, 2008 | Not classified | Z-2577-2011 | Software design | XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct. |
The 5 latest of 12 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 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K102216 (Computerized Medical Systems, Inc., 2010) has gone furthest, with 27 descendants of its own.
- 2 other devices also cite its predicate K032762.
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. 2009, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092132: Xio RTP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092132
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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