# K233236: Radiance V5

- Pathway: 510(k) (Traditional)
- Applicant: Gmv Soluciones Globales Internet S.A.U.
- Decided: May 17, 2024 after 232 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 13 generations back to K864210 (1986). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171885: Radiance V4, Gmv Soluciones Globales Internet S.A.U. (2017) Summary page 4.

## Indications for use
Radiance V5 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V5 shall be clinically qualified radiation therapy staff trained in using the system.

Source page: https://510kreport.com/device/K233236
Methodology: https://510kreport.com/methodology