# K150547: .decimal Astroid Dosimetry App

- Pathway: 510(k) (Traditional)
- Applicant: .Decimal, Inc.
- Decided: May 15, 2015 after 73 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: 8 generations back to K862643 (1987). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002312: Proton Vision 7.0, Varian Medical Systems, Inc. (2000) Summary page 5.
- K130617: Raystation, Raysearch Laboratories AB (2013) Summary page 5.

## Indications for use
The .decimal astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments. The Dosimetry App serves as a tool which provides tested and validated calculation and design functions for use in other end-user applications. The Dosimetry App provides access to the functions that make up what is considered much of the core components of a typical proton treatment planning system. Through the use of these functions in user generated scripts or programs, users will be able to design and/or analyze proton treatment plans for regular and irregular fields using custom designed blocks and range compensators. Additionally, the functions provided by this device can also allow users to generate programs and scripts capable of performing treatment preparation and plan analysis tasks, such as structure/contour modification, image data analysis, and secondary dose calculation checks. Users should be experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes.

Source page: https://510kreport.com/device/K150547
Methodology: https://510kreport.com/methodology