510(k) · Cleared
Cleared.decimal Astroid Dosimetry App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
.Decimal, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 15, 2015 as substantially equivalent to K002312 (Varian Medical Systems, Inc., 2000) and 1 other predicate after a 73-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- May 15, 2015
- Review
- 73 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K862643 (1987). 49 ancestors in all, the oldest K802809 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 7 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 6 generations backK031349 OTP 1.2Nucletron Corp. · 2003
- 5 generations backK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
- 4 generations backK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled
- 3 generations backK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010 · Recalled
- 2 generations backK120387 RaystationRaysearch Laboratories AB · 2012 · Recalled
- 1 generation backK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- This deviceK150547 .decimal Astroid Dosimetry App.Decimal, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −7 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −6 | K031349 | OTP 1.2 | Nucletron Corp. | 2003 | — |
| −5 | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | 2 |
| −4 | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | 2 |
| −3 | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | 4 |
| −2 | K120387 | Raystation | Raysearch Laboratories AB | 2012 | 6 |
| −1 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| 0 (this device) | K150547 | .decimal Astroid Dosimetry App | .Decimal, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002312 | Proton Vision 7.0Summary page 5…proton aperture and range compensator device design algorithms, and other low-level radiotherapy specific calculation functions. Predicate Device(s): Proton Vision 7.0 K002312 RayStation 3.5 K130617 Intended Use: The intended use for the Astroid Dosimetry application is to aid software developers in acc… | 2000 |
| * | K130617 | RaystationSummary page 5…ge compensator device design algorithms, and other low-level radiotherapy specific calculation functions. Predicate Device(s): Proton Vision 7.0 K002312 RayStation 3.5 K130617 Intended Use: The intended use for the Astroid Dosimetry application is to aid software developers in accessing calculation func… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 49 ancestors have a recall of any class.
- 2 other devices also cite its predicate K002312.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
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…
Read the full statement (161 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150547: .decimal Astroid Dosimetry App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150547
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026