# K260597: Virtue QA

- Pathway: 510(k) (Traditional)
- Applicant: ProNova Solutions
- Decided: Sep 23, 2026 after 211 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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: 12 generations back to K954874 (1996). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201798: myQA iON, Iba Dosimetry GmbH (2020) Summary page 5.

## Indications for use
VIRTUE QA is an integrated software platform for patient-specific quality assurance, treatment plan verification, and patient setup review in proton radiation therapy. VIRTUE QA supports QA activities performed both before and during the course of treatment for all patient populations receiving proton radiation therapy. VIRTUE QA is not a treatment planning system. It does not generate, modify, or transmit instructions to any treatment delivery device, nor does it control any aspect of treatment delivery to patients.

Source page: https://510kreport.com/device/K260597
Methodology: https://510kreport.com/methodology