510(k) · Cleared
Cleared3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adaptiiv · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 19, 2022 as substantially equivalent to K180289 (3D Bolus, Inc., 2018) after an 89-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Jan 19, 2022
- Review
- 89 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K971367 (1997). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK971367 Brainscan Conformal RT ModuleBrainlab AG · 1997
- 5 generations backK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
- 4 generations backK061440 P.D.Decimal, Inc. · 2006
- 3 generations backK083672 P.D Software.Decimal, Inc. · 2009
- 2 generations backK151369 .decimal p.d.Decimal, LLC · 2015
- 1 generation backK180289 3D Bolus Software3D Bolus, Inc. · 2018
- This deviceK213438 3D Bolus Software Application, 3D Brachy Software Application…Adaptiiv · 2022
- Descendant · cites it directly · 1 of its ownK243057 TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260308 TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241318 Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K243057TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. · 2024 · cites it directly1descendant
- K260308TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026 · 2 generations on0descendants
- K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971367 | Brainscan Conformal RT Module | Brainlab AG | 1997 | — |
| −5 | K032762 | Xio Radiation Treatment Planning System | Computerized Medical Systems, Inc. | 2003 | — |
| −4 | K061440 | P.D | .Decimal, Inc. | 2006 | — |
| −3 | K083672 | P.D Software | .Decimal, Inc. | 2009 | — |
| −2 | K151369 | .decimal p.d | .Decimal, LLC | 2015 | — |
| −1 | K180289 | 3D Bolus Software | 3D Bolus, Inc. | 2018 | — |
| 0 (this device) | K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched… | Adaptiiv | 2022 | — |
| +1 | K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | 2024 | — |
| +2 | K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180289 | 3D Bolus SoftwareSummary page 4…892.5050 Device Class Class II Predicate Device 3D Bolus Software, Adaptiiv Medical Technologies Inc., K180289 Establishment registration: 3014873236 Device Description Adaptiiv Medical Technologies Inc. solutio… | 2018 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K243057 (Adaptiiv Medical Technologies, Inc., 2024) has gone furthest, with 1 descendant of its own.
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. 2022, 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 and 3D Brachy applications are indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Stereolithography (STL) files to Adaptiiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories…
Read the full statement (143 words)
3D Bolus and 3D Brachy applications are indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Stereolithography (STL) files to Adaptiiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories to the specification of the prescribing radiation therapy professional or 3D print either external beam or surface brachytherapy accessories in-house. If 3D printing is performed by Adaptiiv Medical Technologies Inc., 3D printed accessories will be sent to the requesting care center for the final quality control and acceptance by the trained radiation therapy personnel. The use of 3D Bolus and 3D Brachy applications as well as the 3D printed radiation therapy accessories is by prescription only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213438 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213438: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213438
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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