510(k) · Cleared
ClearedThinkQA 3
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 Jun 12, 2026 as substantially equivalent to K231573 (Dosisoft SA, 2024) after a 270-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jun 12, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010464 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K231573 | ThinkQA (Edition 2)Summary page 5…Product Code: IYE, MUJ 4. Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231573 ThinkQA (Edition 2) IYE Reference # Reference device Trade… | 2024 |
| † | K112723 | Epigray | 2012 |
| † | K172534 | LINACwatch, LinacView | 2017 |
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 25 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 3 is a software medical device designed for Patient-Specific Quality Assurance (QA) in External Beam Radiation Therapy (RT). ThinkQA 3 is intended to help verify that each patient’s treatment is delivered as planned, by identifying discrepancies between treatment plan and actual delivery. ThinkQA 3 consists of a software platform and a suite of independent and complementary verifications. For each patient, ThinkQA 3 imports treatment plan data…
Read the full statement (205 words)
ThinkQA 3 is a software medical device designed for Patient-Specific Quality Assurance (QA) in External Beam Radiation Therapy (RT).
ThinkQA 3 is intended to help verify that each patient’s treatment is delivered as planned, by identifying discrepancies between treatment plan and actual delivery.
ThinkQA 3 consists of a software platform and a suite of independent and complementary verifications. For each patient, ThinkQA 3 imports treatment plan data and treatment machine information, such as delivery logs and EPID (Electronic Portal Image Device) images. ThinkQA 3 verifications are performed either (1) pre-treatment, or (2) post-treatment with data collected during actual treatment delivery (in vivo). ThinkQA 3 is designed for integration into both standard RT and Adaptive RT (ART) workflows.
ThinkQA 3 verifications operate independently, offering distinct insights into treatment delivery quality. With these, the clinical users can better assess proper treatment course, identify possible root causes of detected errors, evaluate clinical relevance, and assist in treatment adaptation if necessary.
ThinkQA 3 is intended for use only by qualified healthcare professionals trained in radiation therapy QA procedures. ThinkQA 3 does not recommend clinical interventions, nor directly control or modify treatment delivery. All clinical decisions must be made by qualified professionals based on their judgment and full clinical context.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252937: ThinkQA 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252937
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026