510(k) Report

510(k) · Cleared

Cleared

decimal3D

K192554510(k) TraditionalCleared Dec 13, 201987-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 Dec 13, 2019 as substantially equivalent to K151369 (.Decimal, LLC, 2015) after an 87-day review. Its family tree reaches back 5 generations to 1997.

Decided
Dec 13, 2019
Review
87 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. No later device cites it as a predicate yet.

  1. Root · 5 generations backK971367 Brainscan Conformal RT ModuleBrainlab AG · 1997
  2. 4 generations backK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
  3. 3 generations backK061440 P.D.Decimal, Inc. · 2006
  4. 2 generations backK083672 P.D Software.Decimal, Inc. · 2009
  5. 1 generation backK151369 .decimal p.d.Decimal, LLC · 2015
  6. This deviceK192554 decimal3D.Decimal, LLC · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K971367Brainscan Conformal RT ModuleBrainlab AG1997—
−4K032762Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc.2003—
−3K061440P.D.Decimal, Inc.2006—
−2K083672P.D Software.Decimal, Inc.2009—
−1K151369.decimal p.d.Decimal, LLC2015—
0 (this device)K192554decimal3D.Decimal, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K192554, 1997–2019Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K151369.decimal p.d
Summary page 5
…. This acrylic template is then scanned using a flatbed document scanner and the shape is digitized in 2D using the predicate software. Predicate Device(s): .decimal p.d K151369 Intended Use: The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radi…
.Decimal, LLC2015—

Also cleared against K151369: 1 other device →

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 22 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 1 other device also cites its predicate K151369.

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. 2019, 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 primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiation therapy beam-shaping block devices through the use of optical scanning technology. This device will serve as a direct replacement to the current processes for designing such radiotherapy devices in cases where a “clinical patient set up” is used (i.e. cases where the treatment field is determined by direct physician examination, not by…

Read the full statement (214 words)

The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiation therapy beam-shaping block devices through the use of optical scanning technology. This device will serve as a direct replacement to the current processes for designing such radiotherapy devices in cases where a “clinical patient set up” is used (i.e. cases where the treatment field is determined by direct physician examination, not by internal imaging technology).

This product is not intended to replace CT imaging or other internal imaging modalities and should be used only in cases where a qualified radiation oncologist has made appropriate determination of the acceptability of a “clinical patient set up” approach, independent of any information provided by this application. In other words, the role of this product is to simply ensure efficient and accurate ordering of a patient-specific beam-shaping block device from our company, in cases where a licensed radiation oncologist has predetermined that such a device and treatment approach is appropriate for the patient at hand. Thus this device’s indications for use include patients with a variety of cancer and disease conditions, which will be treated under the direct supervision and guidance of a radiation oncologist that has prescribed a desired dose of radiation to be delivered to the patient.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K192554: decimal3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192554

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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