510(k) Report

510(k) · Cleared

Cleared

Astroid Planning App

K173940510(k) TraditionalCleared May 15, 2018140-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

.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.

Other ancestors, by year cleared 2014: 1 other ancestor2013: 1 other ancestor2010: 2 other ancestors2012: 1 other ancestor2009: 2 other ancestors2002: 3 other ancestors2000: 5 other ancestors2011: 1 other ancestor2008: 3 other ancestors2007: 1 other ancestor2003: 2 other ancestors2001: 5 other ancestors1999: 4 other ancestors1997: 2 other ancestors1996: 5 other ancestors2006: 2 other ancestors2005: 1 other ancestor2004: 2 other ancestors1992: 4 other ancestors1991: 1 other ancestor1994: 2 other ancestors1990: 2 other ancestors1989: 2 other ancestors1987: 1 other ancestor1986: 1 other ancestor1981: 1 other ancestorReference device: K150547 · .decimal Astroid Dosimetry App · .Decimal, Inc. · 2015K010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalledK030981 · Eclipse · Varian Medical Systems, Inc. · 2003K041403 · Eclipse with Aaa · Varian Medical Systems · 2004K050296 · Eclipse Treatment Planning System · Varian Medical Systems · 2005×2: 2 generations cleared close together, K071873 (2007), K073020 (2007) K091492 · Modification to Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2009 · recalledK102011 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2010 · recalled×2: 2 generations cleared close together, K131891 (2013), K133247 (2014) K141283 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2014 · recalledK152393 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2015 · recalled×2: 2 generations cleared close together, K170969 (2017), K172163 (2017) 19801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 7 other ancestors5 generations back: 11 other ancestors6 generations back: 14 other ancestors7 generations back: 14 other ancestors8 generations back: 4 other ancestors K172163 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2017 · recalledK170969 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2017 · recalledK152393 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2015 · recalledK141283 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2014 · recalledK133247 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2014K131891 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2013K102011 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2010 · recalledK091492 · Modification to Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2009 · recalledK073020 · Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2007 · recalledK071873 · Modification to Eclipse Treatment Planning System · Varian Medical Systems, Inc. · 2007 · recalledK050296 · Eclipse Treatment Planning System · Varian Medical Systems · 2005K041403 · Eclipse with Aaa · Varian Medical Systems · 2004K030981 · Eclipse · Varian Medical Systems, Inc. · 2003K010975 · Eclipse 6.5 · Varian Medical Systems, Inc. · 2001 · recalled−10−50
  1. Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
  2. 10 generations between
  3. 3 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
  4. 2 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
  5. 1 generation backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
  6. This deviceK173940 Astroid Planning App.Decimal, LLC · 2018
Show all 14 generations
  1. Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
  2. 13 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
  3. 12 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
  4. 11 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
  5. 10 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  6. 9 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
  7. 8 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
  8. 7 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
  9. 6 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
  10. 5 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
  11. 4 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
  12. 3 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
  13. 2 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
  14. 1 generation backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
  15. This deviceK173940 Astroid Planning App.Decimal, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K010975Eclipse 6.5Varian Medical Systems, Inc.20013
−13K030981EclipseVarian Medical Systems, Inc.2003—
−12K041403Eclipse with AaaVarian Medical Systems2004—
−11K050296Eclipse Treatment Planning SystemVarian Medical Systems2005—
−10K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20075
−9K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20076
−8K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20092
−7K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20105
−6K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2013—
−5K133247Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2014—
−4K141283Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20141
−3K152393Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20151
−2K170969Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20171
−1K172163Eclipse Treatment Planning SystemVarian Medical Systems, Inc.20171
0 (this device)K173940Astroid Planning App.Decimal, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198610
198710
198920
199020
199110
199240
199420
199650
199720
199940
200050
200150
200230
200320
200420
200510
200620
200710
200830
200920
201020
201110
201210
201310
201410
FIG. 1 — Lineage of K173940, 2001–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K172163Eclipse Treatment Planning System
Summary 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…
Varian Medical Systems, Inc.20171
*K140187Ray Station
Summary 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…
Raysearch Laboratories AB20141
†K150547.decimal Astroid Dosimetry App.Decimal, Inc.2015—

Also cleared against K172163: 2 other devices →

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 devices

MUJ 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

2007: 42008: 92009: 162010: 112011: 92012: 82013: 52014: 92015: 132016: 52017: 72018: 72019: 92020: 92021: 112022: 82023: 102024: 92025: 102026 (partial year): 9
2007high 16 (2009) · low 4 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUJ

186in 2025

2007: 67 days median2008: 63 days median2009: 84 days median2010: 56 days median2011: 103 days median2012: 59 days median2013: 64 days median2014: 108 days median2015: 78 days median2016: 80 days median2017: 30 days median2018: 53 days median2019: 56 days median2020: 104 days median2021: 87 days median2022: 168 days median2023: 140 days median2024: 122 days median2025: 186 days median2026 (partial year): 233 days median
2007high 233 (2026) · low 30 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUJ

2in 2023

2007: 42008: 102009: 112010: 232011: 172012: 42013: 62014: 22015: 72016: 132017: 42018: 32019: 42020: 22021: 42022: 32023: 22026 (partial year): 2
2007high 23 (2010) · low 0 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUJ

21in 2025

2007: 242008: 512009: 242010: 782011: 732012: 392013: 332014: 352015: 302016: 272017: 162018: 252019: 252020: 262021: 152022: 222023: 762024: 92025: 21
2007high 78 (2010) · low 9 (2024)2025

MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007467424
20089631051
200916841124
201011562378
201191031773
2012859439
2013564633
20149108235
20151378730
20165801327
2017730416
2018753325
2019956425
20209104226
20211187415
20228168322
202310140276
2024912209
202510186021
202692332—

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.

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