510(k) · Cleared
ClearedThinkQA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dosisoft · IYE Accelerator, Linear, Medical
Cleared on Mar 13, 2018 as substantially equivalent to K133572 (Varian Medical Systems, Inc., 2014) after a 56-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 13, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K952313 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
- 3 generations backK042956 VisionVarian Medical Systems, Inc. · 2005
- 2 generations backK093527 Aria Radiation Oncology with MirsVarian Medical Systems, Inc. · 2009 · Recalled
- 1 generation backK133572 Aria Radiation Therapy ManagementVarian Medical Systems, Inc. · 2014 · Recalled
- This deviceK180106 ThinkQADosisoft · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | 1995 | — |
| −3 | K042956 | Vision | Varian Medical Systems, Inc. | 2005 | — |
| −2 | K093527 | Aria Radiation Oncology with Mirs | Varian Medical Systems, Inc. | 2009 | 9 |
| −1 | K133572 | Aria Radiation Therapy Management | Varian Medical Systems, Inc. | 2014 | 1 |
| 0 (this device) | K180106 | ThinkQA | Dosisoft | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K133572 | Aria Radiation Therapy ManagementSummary page 5…al charged-particle radiation therapy system (Class II, 21 CFR 892.5050, Product Code IYE) 4. Predicate Device: K133572 – ARIA Radiation Therapy Management - “Enhanced Portal Dosimetry gamma evaluation” feature – Varian Medical Systems, Inc. Execut… | 2014 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K133572.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 is a radiation therapy dosimetry Quality Assurance (QA) device consisting of a software framework intended to contain a suite of modules to verify that radiation dose actually delivered to the patient is as intended. The Epibeam module contained in ThinkQA is intended to be used as follows: Epibeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing…
Read the full statement (348 words)
ThinkQA is a radiation therapy dosimetry Quality Assurance (QA) device consisting of a software framework intended to contain a suite of modules to verify that radiation dose actually delivered to the patient is as intended.
The Epibeam module contained in ThinkQA is intended to be used as follows:
Epibeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the presence of the patient and subsequently processes it. The processed data is compared with data calculated by the Epibeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
Epibeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data.
Epibeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy).
Epibeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180106 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180106: ThinkQA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180106
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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