# K191944: MU2net

- Pathway: 510(k) (Traditional)
- Applicant: Dosisoft
- Decided: Oct 24, 2019 after 94 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: 2 generations back to K010464 (2001). 2 ancestors in all.
2 later devices descend 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)
- K031975: Imsure, Prodigm, Inc. (2003) Summary page 4.

## Most influential descendants
- K231573: ThinkQA (Edition 2) (2024), 1 descendant of its own
- K252937: ThinkQA 3 (2026), 0 descendants of its own

## Indications for use
Treatment plan verification System by double Monitor Units calculation and in vivo verifications management. MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets. It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions. MU2net is dedicated to be used by high qualified professionals in medical oncology and/or medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.

Source page: https://510kreport.com/device/K191944
Methodology: https://510kreport.com/methodology