# K180106: ThinkQA

- Pathway: 510(k) (Traditional)
- Applicant: Dosisoft
- Decided: Mar 13, 2018 after 56 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 K952313 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133572: Aria Radiation Therapy Management, Varian Medical Systems, Inc. (2014) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K180106
Methodology: https://510kreport.com/methodology