510(k) · Cleared
Cleared3D Bolus Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Bolus, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 10, 2018 as substantially equivalent to K151369 (.Decimal, LLC, 2015) after a 159-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 10, 2018
- Review
- 159 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K971367 (1997). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK971367 Brainscan Conformal RT ModuleBrainlab AG · 1997
- 4 generations backK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
- 3 generations backK061440 P.D.Decimal, Inc. · 2006
- 2 generations backK083672 P.D Software.Decimal, Inc. · 2009
- 1 generation backK151369 .decimal p.d.Decimal, LLC · 2015
- This deviceK180289 3D Bolus Software3D Bolus, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK213438 3D Bolus Software Application, 3D Brachy Software Application…Adaptiiv · 2022
- Descendant · 2 generations on · 1 of its ownK243057 TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK260308 TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241318 Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D…Adaptiiv · 2022 · cites it directly3descendants
- K243057TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. · 2024 · 2 generations on1descendant
- K260308TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026 · 3 generations on0descendants
- K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971367 | Brainscan Conformal RT Module | Brainlab AG | 1997 | — |
| −4 | K032762 | Xio Radiation Treatment Planning System | Computerized Medical Systems, Inc. | 2003 | — |
| −3 | K061440 | P.D | .Decimal, Inc. | 2006 | — |
| −2 | K083672 | P.D Software | .Decimal, Inc. | 2009 | — |
| −1 | K151369 | .decimal p.d | .Decimal, LLC | 2015 | — |
| 0 (this device) | K180289 | 3D Bolus Software | 3D Bolus, Inc. | 2018 | — |
| +1 | K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched… | Adaptiiv | 2022 | — |
| +2 | K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | 2024 | — |
| +3 | K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026 | — |
| +2 | K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (1)
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.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D… | 2022 | 3 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K213438 (Adaptiiv, 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K151369.
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?
3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180289: 3D Bolus Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180289
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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