# K040474: Accusoft

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Jun 23, 2004 after 120 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 K993895 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032171: Accusoft, Direx Systems Corp. (2003) Summary page 2.
- K001163: DMLC IV-Ergo, 3D Line USA, Inc. (2000)

## Most influential descendants
- K062032: Accusoft, Accusoft XL (2006), 1 descendant of its own
- K063482: Crossplan / Accusoft-XL V.4.04 (2006), 0 descendants of its own

## Indications for use
Accusoft is to be used for the computation, display, evaluation, and output documentation of radiation dose estimations including those for Intensity Modulated Radiation Treatment (IMRT), to be submitted for independent clinical review and judgment by a physicist or physician prior to use. The device provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

Source page: https://510kreport.com/device/K040474
Methodology: https://510kreport.com/methodology