# K981597: Radionics Slice Editor Imaging Software Utility

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Oct 9, 1998 after 158 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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 K946252 (1995). 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)
- K972905: XPLAN-1, Radionics Software Applications, Inc. (1997) Summary page 1.
- K946252: Stereoplan, Radionics Software Applications, Inc. (1995) Summary page 1.

## Indications for use
The Slice Editor Imaging Software Utility is an image manipulation and contouring software package for use in surgical and treatment planning. The Slice Editor can replace the IMEX contouring utility as the component for contouring anatomies in all applications in which IMEX is currently utilized.

Source page: https://510kreport.com/device/K981597
Methodology: https://510kreport.com/methodology