510(k) · Cleared
ClearedMU2net
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dosisoft · IYE Accelerator, Linear, Medical
Cleared on Oct 24, 2019 as substantially equivalent to K031975 (Prodigm, Inc., 2003) after a 94-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 24, 2019
- Review
- 94 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010464 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010464 Radcalc, Model V.4.0Lifeline Software, Inc. · 2001
- 1 generation backK031975 ImsureProdigm, Inc. · 2003
- This deviceK191944 MU2netDosisoft · 2019
- Descendant · cites it directly · 1 of its ownK231573 ThinkQA (Edition 2)Dosisoft SA · 2024
- Descendant · 2 generations on · 0 of its ownK252937 ThinkQA 3Dosisoft SA · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010464 | Radcalc, Model V.4.0 | Lifeline Software, Inc. | 2001 | — |
| −1 | K031975 | Imsure | Prodigm, Inc. | 2003 | — |
| 0 (this device) | K191944 | MU2net | Dosisoft | 2019 | — |
| +1 | K231573 | ThinkQA (Edition 2) | Dosisoft SA | 2024 | — |
| +2 | K252937 | ThinkQA 3 | Dosisoft SA | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K031975 | ImsureSummary page 4…ical charged-particle radiation therapy system (21 CFR 892.5050, Class II, Product Code IYE) 4. Predicate Device: K031975 – IMSure QA Software – Standard Imaging, Inc. (Prodigm, Inc.) Executive Summary 5. Product Description: MU2net is a standalone… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231573 | ThinkQA (Edition 2) | 2024 | 1 |
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 3 companies; a new generation was cleared every 16.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231573 (Dosisoft SA, 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K031975.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
Treatment plan verification System by double Monitor Units calculation and in vivo verifications management.
MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets.
It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions.
MU2net is dedicated to be used by high qualified professionals in medical oncology and/or medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191944: MU2net.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191944
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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