# K032171: Accusoft

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Dec 15, 2003 after 152 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 K993895 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993895: Optirad, Permedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K040474: Accusoft (2004), 2 descendants of its own
- 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 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/K032171
Methodology: https://510kreport.com/methodology