# K171885: Radiance V4

- Pathway: 510(k) (Special)
- Applicant: Gmv Soluciones Globales Internet S.A.U.
- Decided: Jul 25, 2017 after 29 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: 12 generations back to K864210 (1986). 63 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153368: Radiance V3, Gmv Soluciones Globales Internet S.A.U. (2016) Summary page 4.

## Most influential descendants
- K233236: Radiance V5 (2024), 0 descendants of its own
- K182665: Sensus TPS Workstation (2019), 0 descendants of its own
- K180308: Prelude (2018), 0 descendants of its own

## Indications for use
Radiance V4 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 V4 shall be clinically qualified radiation therapy staff trained in using the system.

Source page: https://510kreport.com/device/K171885
Methodology: https://510kreport.com/methodology