510(k) · Cleared
ClearedThinkQA (Edition 2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dosisoft SA · IYE Accelerator, Linear, Medical
Cleared on Jan 18, 2024 as substantially equivalent to K191944 (Dosisoft, 2019) after a 232-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Jan 18, 2024
- Review
- 232 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010464 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK010464 Radcalc, Model V.4.0Lifeline Software, Inc. · 2001
- 2 generations backK031975 ImsureProdigm, Inc. · 2003
- 1 generation backK191944 MU2netDosisoft · 2019
- This deviceK231573 ThinkQA (Edition 2)Dosisoft SA · 2024
- Descendant · cites it directly · 0 of its ownK252937 ThinkQA 3Dosisoft SA · 2026
Most influential descendants
Showing 1 of 1 · See all- K252937ThinkQA 3Dosisoft SA · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010464 | Radcalc, Model V.4.0 | Lifeline Software, Inc. | 2001 | — |
| −2 | K031975 | Imsure | Prodigm, Inc. | 2003 | — |
| −1 | K191944 | MU2net | Dosisoft | 2019 | — |
| 0 (this device) | K231573 | ThinkQA (Edition 2) | Dosisoft SA | 2024 | — |
| +1 | K252937 | ThinkQA 3 | Dosisoft SA | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K191944 | MU2netSummary page 4…Classification Name: Accelerator, Linear, Medical – Regulation Number: 892.5050 – Product Code: IYE 4. Legally Marketed Predicate Devices – Predicate # K191944 – Predicate Trade Name (Primary Predicate is listed first): MU2net – Product Code: IYE… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252937 | ThinkQA 3 | 2026 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252937 (Dosisoft SA, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
ThinkQA Edition 2 software is used to verify that the dose distribution calculated by a treatment planning system for external beam radiation therapy is consistent with treatment plan parameters.
Based on read-in treatment plan data, ThinkQA Edition 2 re-calculates a dose distribution in a three-dimensional representation of a patient or a phantom and provides dose-volume indicators which compare it to the initial dose distribution calculated by the treatment planning system.
ThinkQA Edition 2 is not a treatment planning system. It is a Quality Assurance software only to be used by qualified and trained radiation therapy personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231573: ThinkQA (Edition 2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231573
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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