# K231573: ThinkQA (Edition 2)

- Pathway: 510(k) (Traditional)
- Applicant: Dosisoft SA
- Decided: Jan 18, 2024 after 232 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: 3 generations back to K010464 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191944: MU2net, Dosisoft (2019) Summary page 4.

## Most influential descendants
- K252937: ThinkQA 3 (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K231573
Methodology: https://510kreport.com/methodology