# K102216: Xio RTP System

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Oct 1, 2010 after 56 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010975 (2001). 27 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092132: Xio RTP System, Computerized Medical Systems, Inc. (2009) Summary page 2.
- K091492: Modification to Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2009) Summary page 2.

## Most influential descendants
- K140187: Ray Station (2014), 19 descendants of its own
- K141860: Raystation (2014), 17 descendants of its own
- K160093: RayStation (2016), 16 descendants of its own
- K170355: RayStation 6 (2017), 15 descendants of its own
- K171536: RayStation (2017), 13 descendants of its own

## Recalls of this device
- Aug 31, 2015 · Class II · Z-0130-2016: Incorrect Treatment Delivery Using Third Party Fixed Wedges.
- Feb 17, 2014 · Class II · Z-1197-2014: 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: 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 pl
- Nov 25, 2013 · Class II · Z-0928-2014: 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: 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: 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 
- Nov 16, 2010 · Not classified · Z-2582-2011: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K102216
Methodology: https://510kreport.com/methodology