# K032762: Xio Radiation Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Dec 2, 2003 after 88 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971367 (1997). 2 ancestors in all.
52 later devices descend from it; 3 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)
- K971367: Brainscan Conformal RT Module, Brainlab AG (1997) Summary page 1.
- K001163: DMLC IV-Ergo, 3D Line USA, Inc. (2000)

## Most influential descendants
- K092132: Xio RTP System (2009), 34 descendants of its own
- 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

## 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. 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.

Source page: https://510kreport.com/device/K032762
Methodology: https://510kreport.com/methodology