# K092132: Xio RTP System

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Sep 24, 2009 after 71 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010975 (2001). 23 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032762: Xio Radiation Treatment Planning System, Computerized Medical Systems, Inc. (2003) Summary page 2.
- K071760: Modification to: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2007) Summary page 2.
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy), Nucletron Corporation (2008) Summary page 2.

## Most influential descendants
- K102216: Xio RTP System (2010), 27 descendants of its own
- 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

## Recalls of this device
- Oct 3, 2010 · Not classified · Z-2579-2011: 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 ne
- Sep 10, 2010 · Not classified · Z-2408-2011: 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: 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 th
- May 27, 2010 · Not classified · Z-2593-2011: 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 
- May 27, 2010 · Not classified · Z-2407-2011: 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: 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 a
- Apr 15, 2010 · Not classified · Z-1655-2010: 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: Inconsistent MLC positions, dose, and monitor units
- May 13, 2009 · Not classified · Z-2568-2011: 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, 
- Dec 9, 2008 · Not classified · Z-2567-2011: 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 distribut
- May 14, 2008 · Not classified · Z-2574-2011: 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: 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.

## 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/K092132
Methodology: https://510kreport.com/methodology