# K252937: ThinkQA 3

- Pathway: 510(k) (Traditional)
- Applicant: Dosisoft SA
- Decided: Jun 12, 2026 after 270 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010464 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231573: ThinkQA (Edition 2), Dosisoft SA (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K252937
Methodology: https://510kreport.com/methodology