# K083414: Radionics Xknife HDRT System

- Pathway: 510(k) (Traditional)
- Applicant: Integra Radionics, Inc.
- Decided: Mar 2, 2009 after 104 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: 6 generations back to K913119 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081188: Trilogy with External System Gating Interface, Varian Medical Systems, Inc. (2008) Summary page 1.

## Indications for use
The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

Source page: https://510kreport.com/device/K083414
Methodology: https://510kreport.com/methodology