# K990071: Imagefusion 2.0

- Pathway: 510(k) (Special)
- Applicant: Radionics, Inc.
- Decided: Feb 8, 1999 after 28 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 K960071 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960071: Imagefusion, Radionics Software Applications, Inc. (1996) Summary page 1.

## Most influential descendants
- K063230: Integra Radionics Imagefusion 3 (2006), 0 descendants of its own

## 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/K990071
Methodology: https://510kreport.com/methodology