510(k) · Cleared
ClearedAstroid Planning App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
.Decimal, LLC · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 15, 2018 as substantially equivalent to K172163 (Varian Medical Systems, Inc., 2017) and 1 other predicate after a 140-day review. Its family tree reaches back 14 generations to 2001.
- Decided
- May 15, 2018
- Review
- 140 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K010975 (2001). 71 ancestors in all, the oldest K802809 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 10 generations between
- 3 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 2 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- This deviceK173940 Astroid Planning App.Decimal, LLC · 2018
Show all 14 generations
- Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 13 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 12 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 11 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 10 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 9 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 8 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 7 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 6 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 5 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 4 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 3 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 2 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- This deviceK173940 Astroid Planning App.Decimal, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −13 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −12 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −11 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −10 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −9 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −8 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −7 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −6 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −5 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −4 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −3 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −2 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −1 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| 0 (this device) | K173940 | Astroid Planning App | .Decimal, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K172163 | Eclipse Treatment Planning SystemSummary page 5…eraging the functions externally located in the Astroid Dosimetry App to then perform the requested calculations. Predicate Device(s): Eclipse Treatment Planning System K172163 RayStation 4.0.2 K140187 Intended Use: The Astroid Planning App is an interactive end user application that leverages the existi… | 2017 |
| * | K140187 | Ray StationSummary page 5…ernally located in the Astroid Dosimetry App to then perform the requested calculations. Predicate Device(s): Eclipse Treatment Planning System K172163 RayStation 4.0.2 K140187 Intended Use: The Astroid Planning App is an interactive end user application that leverages the existing .decimal Astroid Dosim… | 2014 |
| † | K150547 | .decimal Astroid Dosimetry App | 2015 |
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 17 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 24 of the 71 ancestors have a recall of any class.
- 2 other devices also cite its predicate K172163.
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. 2018, 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 Astroid Planning App is an interactive end user application for proton treatment planning for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans. This Astroid Planning App leverages the existing .decimal Astroid Dosimetry App [FDA 510(k) K150547], which is a library of treatment planning functions accessed through the Thinknode® cloud services framework…
Read the full statement (314 words)
The Astroid Planning App is an interactive end user application for proton treatment planning for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans. This Astroid Planning App leverages the existing .decimal Astroid Dosimetry App [FDA 510(k) K150547], which is a library of treatment planning functions accessed through the Thinknode® cloud services framework, for device creation, dose calculation, optimization, and all other dosimetry and processing calculations. Since the Astroid Dosimetry App is responsible for performing the calculations, the scope of this Astroid Planning App is to be the user interface for end users to input treatment planning data and review the results. Typical indications for use of this application are for the treatment of persons with cancer, over a wide range of potential disease locations. In the most common use case of the software, users will import patient data from existing imaging and contouring software programs, manage physician prescription and intent information, develop a proton treatment plan, and analyze the plan to determine how well it meets the physician’s goals. Since the critical treatment planning functions and calculations are handled outside this software application, by a software of known quality and pedigree, the primary and most frequently used functions of this software are the record keeping service (for patient data storage), user interface controls, and visualization tools.
Furthermore, since the accuracy of information computed and displayed by an application such as this is very important to the proper treatment of patients, it is critical that users have the appropriate educational and clinical experience backgrounds to adequately understand and use the product. Additionally, since each radiotherapy treatment machine produces a unique beam of radiation, there is much responsibility on the end users to adequately commission and test this software over the full range of expected treatment conditions before the system is utilized for patient treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173940: Astroid Planning App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173940
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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