# K083672: P.D Software

- Pathway: 510(k) (Traditional)
- Applicant: .Decimal, Inc.
- Decided: Apr 13, 2009 after 123 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 K971367 (1997). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061440: P.D, .Decimal, Inc. (2006) Summary page 1.

## Most influential descendants
- K151369: .decimal p.d (2015), 6 descendants of its own
- K180289: 3D Bolus Software (2018), 4 descendants of its own
- K213438: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory (2022), 3 descendants of its own
- K243057: TrueFit Bolus; TrueFlex Bolus (2024), 1 descendant of its own
- K260308: TrueFit Bolus (2026), 0 descendants of its own

## Indications for use
The p.d software is used by radiation therapy professionals to assist in the treatment of cancer patients. The p.d software takes a Treatment Planning System design of a compensating filter which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. And the software converts Treatment Planning System compensator filter file into a .decimal file format. Optionally the user may elect to design a beam shaping compensator filter based on Treatment Planning System's data which will be transferred back into the Treatment Planning System for final dose verification. The customer uses the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd and approved by a radiation therapy professional prior to use on a patient.

Source page: https://510kreport.com/device/K083672
Methodology: https://510kreport.com/methodology