# K041997: Radionics Xknife RT 3 with Non Stereotactic Module

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, A Division of Tyco Healthcare Group LP
- Decided: Aug 27, 2004 after 32 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: 5 generations back to K914698 (1992). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013661: Xplan 2.2 with the Body System, Radionics, A Division of Tyco Healthcare Group LP (2001) Summary page 1.
- K981055: Xknife-4, Radionics, Inc. (1998) Summary page 1.
- K032724: PINNACLE3 Radiation Therapy Planning System, Adac Laboratories (2003) Summary page 1.

## Most influential descendants
- K061893: Integra Radionics Xknife RT 4 (2006), 0 descendants of its own

## Indications for use
XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic, collimated beam, computer planned, LINAC based treatment.

Source page: https://510kreport.com/device/K041997
Methodology: https://510kreport.com/methodology