# K013661: Xplan 2.2 with the Body System

- Pathway: 510(k) (Special)
- Applicant: Radionics, A Division of Tyco Healthcare Group LP
- Decided: Dec 3, 2001 after 27 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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 K001700 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001700: XPLAN 2.1, Radionics, Inc. (2000) Summary page 1.
- K001052: Med-Tec (Medical Intelligence) Bodyfix System, Model MT-BFX, Med-Tec,Inc. (2000) Summary page 1.

## Most influential descendants
- K041997: Radionics Xknife RT 3 with Non Stereotactic Module (2004), 1 descendant of its own
- K061893: Integra Radionics Xknife RT 4 (2006), 0 descendants of its own

## Indications for use
XPlan 2.2 software is a stereotactic LINAC-based rz;ggn treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan 2.2 with the Body System provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.

Source page: https://510kreport.com/device/K013661
Methodology: https://510kreport.com/methodology