# K151369: .decimal p.d

- Pathway: 510(k) (Traditional)
- Applicant: .Decimal, LLC
- Decided: Aug 7, 2015 after 78 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: 4 generations back to K971367 (1997). 5 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K083672: P.D Software, .Decimal, Inc. (2009) Summary page 5.

## Most influential descendants
- 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
- K241318: Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) (2024), 0 descendants of its own

## Indications for use
The p.d software is used by radiation therapy professionals to assist in the design, manufacturing, and quality assurance testing of various radiation therapy devices used for cancer patients. The p.d software performs three distinct, primary functions which each are described below. 1) The p.d software takes a design of a compensating filter from a Treatment Planning System and converts the Treatment Planning System compensator filter files into a .decimal file format. This file can then be electronically submitted to .decimal through the software, so that we can manufacture the device. 2) The p.d software can design a beam shaping and compensating filters based on Treatment Planning System and other user supplied data. The device designs for compensating filters will be transferred back into the Treatment Planning System for final dose verification before devices are ordered and used for patient treatment. 3) The p.d software can perform quality assurance testing of the physical characteristics of treatment devices using data from various types of scanned images, including computed tomography images.

Source page: https://510kreport.com/device/K151369
Methodology: https://510kreport.com/methodology