510(k) · Cleared
Cleared.decimal p.d
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 Aug 7, 2015 as substantially equivalent to K083672 (.Decimal, Inc., 2009) after a 78-day review. Its family tree reaches back 4 generations to 1997. 6 later devices descend from it.
- Decided
- Aug 7, 2015
- Review
- 78 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971367 (1997). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK971367 Brainscan Conformal RT ModuleBrainlab AG · 1997
- 3 generations backK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
- 2 generations backK061440 P.D.Decimal, Inc. · 2006
- 1 generation backK083672 P.D Software.Decimal, Inc. · 2009
- This deviceK151369 .decimal p.d.Decimal, LLC · 2015
- Descendant · cites it directly · 4 of its ownK180289 3D Bolus Software3D Bolus, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK213438 3D Bolus Software Application, 3D Brachy Software Application…Adaptiiv · 2022
- Descendant · 3 generations on · 1 of its ownK243057 TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK260308 TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241318 Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K1802893D Bolus Software3D Bolus, Inc. · 2018 · cites it directly4descendants
- K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D…Adaptiiv · 2022 · 2 generations on3descendants
- K243057TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. · 2024 · 3 generations on1descendant
- K260308TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026 · 4 generations on0descendants
- K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971367 | Brainscan Conformal RT Module | Brainlab AG | 1997 | — |
| −3 | K032762 | Xio Radiation Treatment Planning System | Computerized Medical Systems, Inc. | 2003 | — |
| −2 | K061440 | P.D | .Decimal, Inc. | 2006 | — |
| −1 | K083672 | P.D Software | .Decimal, Inc. | 2009 | — |
| 0 (this device) | K151369 | .decimal p.d | .Decimal, LLC | 2015 | — |
| +1 | K180289 | 3D Bolus Software | 3D Bolus, Inc. | 2018 | — |
| +2 | K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched… | Adaptiiv | 2022 | — |
| +3 | K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | 2024 | — |
| +4 | K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083672 | P.D SoftwareSummary page 5…for analyzing scanned image data that aids users in performing quality assurance measurement and testing of radiotherapy devices. Predicate Device(s): K083672 - p.d software (version 5.0) - .decimal, LLC (Primary Predicate Device) K141283 - Eclipse Treatment Planning System - Varian Medi… | 2009 |
| † | K141283 | Eclipse Treatment Planning System | 2014 |
What descends from it? (6)
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 18 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K180289 (3D Bolus, Inc., 2018) has gone furthest, with 4 descendants 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. 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 p.d software is used by radiation therapy professionals to assist in the design, manufacturing, and quality assurance testing of various radiation therapy devices used for cancer patients. The p.d software performs three distinct, primary functions which each are described below. 1) The p.d software takes a design of a compensating filter from a Treatment Planning System and converts the Treatment Planning System compensator filter files into a…
Read the full statement (168 words)
The p.d software is used by radiation therapy professionals to assist in the design, manufacturing, and quality assurance testing of various radiation therapy devices used for cancer patients. The p.d software performs three distinct, primary functions which each are described below.
1) The p.d software takes a design of a compensating filter from a Treatment Planning System and converts the Treatment Planning System compensator filter files into a .decimal file format. This file can then be electronically submitted to .decimal through the software, so that we can manufacture the device.
2) The p.d software can design a beam shaping and compensating filters based on Treatment Planning System and other user supplied data. The device designs for compensating filters will be transferred back into the Treatment Planning System for final dose verification before devices are ordered and used for patient treatment.
3) The p.d software can perform quality assurance testing of the physical characteristics of treatment devices using data from various types of scanned images, including computed tomography images.
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/K151369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151369: .decimal p.d.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151369
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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