# K063230: Integra Radionics Imagefusion 3

- Pathway: 510(k) (Special)
- Applicant: Integra Radionics, Inc.
- Decided: Dec 21, 2006 after 57 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: 2 generations back to K960071 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990071: Imagefusion 2.0, Radionics, Inc. (1999) Summary page 1.

## Indications for use
A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems

Source page: https://510kreport.com/device/K063230
Methodology: https://510kreport.com/methodology