# K201798: myQA iON

- Pathway: 510(k) (Traditional)
- Applicant: Iba Dosimetry GmbH
- Decided: Jul 17, 2020 after 17 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K954874 (1996). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153014: Mobius3D, Mobius Medical Systems, LP (2016) Summary page 6.

## Most influential descendants
- K260597: Virtue QA (2026), 0 descendants of its own

## Recalls of this device
- Apr 1, 2025 · Class II · Z-1703-2025: Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

## Indications for use
The intended use of the myQA iON product is to perform patient quality assurance activities for radiation therapy treatment delivery systems. myQA iON is a software toolbox allowing the Medical Physicist to perform quality assurance activities before and after the patient treatment fractions for all patients undergoing radiation therapy.

Source page: https://510kreport.com/device/K201798
Methodology: https://510kreport.com/methodology