510(k) · Cleared
Recalled · Class II · 2015Xio 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 Oct 1, 2010 as substantially equivalent to K092132 (Computerized Medical Systems, Inc., 2009) and 1 other predicate after a 56-day review. Its family tree reaches back 7 generations to 2001. 27 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 1, 2010
- Review
- 56 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010975 (2001). 27 ancestors in all, the oldest K862643 (1987). 27 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 5 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 4 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 3 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- This deviceK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010
- Descendant · cites it directly · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 2 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 3 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- Descendant · 4 generations on · 15 of its ownK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- Descendant · 5 generations on · 13 of its ownK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K140187Ray StationRaysearch Laboratories AB · 2014 · cites it directly19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 2 generations on17descendants
- K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 3 generations on16descendants
- K170355RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · 4 generations on15descendants
- K171536RayStationRaySearch Laboratories AB (PUBL) · 2017 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −6 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −4 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −3 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −2 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −1 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| 0 (this device) | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | — |
| +1 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +2 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| +3 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| +4 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
| +5 | K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017 | 6 |
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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092132 | Xio RTP 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. K092132 2. Eclipse Treatment Planning System Varian Medical Systems K09 1492 XIO INTENDED USE The XiO RTP System is… | 2009 |
| * | K091492 | Modification to Eclipse Treatment Planning SystemSummary page 2…tiveness. 1. XiO RTP System Computerized Medical Systems, Inc. K092132 2. Eclipse Treatment Planning System Varian Medical Systems K09 1492 XIO INTENDED USE The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation t… | 2009 |
What descends from it? (27)
See all 272 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 |
|---|---|---|---|---|
| Aug 31, 2015 | Class II | Z-0130-2016 | Software design | Incorrect Treatment Delivery Using Third Party Fixed Wedges. |
| Feb 17, 2014 | Class II | Z-1197-2014 | Software design | Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs. |
| Nov 25, 2013 | Class II | Z-0780-2014 | Software Design Change | When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan. |
| Nov 25, 2013 | Class II | Z-0928-2014 | Software design | When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect. |
| Apr 30, 2012 | Not classified | Z-1644-2012 | Software design | XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator. |
| Jun 9, 2011 | Not classified | Z-2919-2011 | Software design | The XiO Software currently prompts for entry of CT to ED data for a studyset. No indication is given that the Electron Density data should only be used for Photon and Electron calculations and either Relative Stopping Power or Mass… |
| Nov 16, 2010 | Not classified | Z-2582-2011 | Other | XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is… |
The 5 latest of 7 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 9 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 27 ancestors have a recall of any class.
- Of its descendants, K140187 (Raysearch Laboratories AB, 2014) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K092132.
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. 2010, 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/K102216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102216: 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/K102216
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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