# K061440: P.D

- Pathway: 510(k) (Traditional)
- Applicant: .Decimal, Inc.
- Decided: Jun 27, 2006 after 34 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 K971367 (1997). 3 ancestors in all.
8 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)
- K032762: Xio Radiation Treatment Planning System, Computerized Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K083672: P.D Software (2009), 7 descendants of its own
- 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

## Indications for use
The p.d software takes a Treatment Planning System design of a compensating filter used for radiation therapy which contains steep, narrow, and unmachinable areas and then smoothes them out into a machinable surface. The customer will use the software in-house before sending the file to .decimal to be manufactured. Each filter must be QA'd by the customer before use on a patient.

Source page: https://510kreport.com/device/K061440
Methodology: https://510kreport.com/methodology