# K062032: Accusoft, Accusoft XL

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Oct 5, 2006 after 79 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: 3 generations back to K993895 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040474: Accusoft, Direx Systems Corp. (2004) Summary page 1.
- K042861: Odyssey, Permedics, Inc. (2005) Summary page 1.

## Most influential descendants
- K063482: Crossplan / Accusoft-XL V.4.04 (2006), 0 descendants of its own

## Indications for use
AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

Source page: https://510kreport.com/device/K062032
Methodology: https://510kreport.com/methodology