# K112060: Radiance

- Pathway: 510(k) (Traditional)
- Applicant: Gmv Aerospace and Defence S.A.
- Decided: Jan 6, 2012 after 171 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: 6 generations back to K862643 (1987). 13 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100552: Raystation Version 1.0, Raysearch Laboratories AB (2010) Summary page 1.

## Most influential descendants
- K133655: Radiance V2 (2014), 5 descendants of its own
- K153368: Radiance V3 (2016), 4 descendants of its own
- K171885: Radiance V4 (2017), 3 descendants of its own
- K233236: Radiance V5 (2024), 0 descendants of its own
- K182665: Sensus TPS Workstation (2019), 0 descendants of its own

## Indications for use
radiance is a software system intended for treatment planning and analysis of intraoperative radiation therapy by means of electron beams. 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 shall be clinically qualified radiation therapy staff trained in using the system.

Source page: https://510kreport.com/device/K112060
Methodology: https://510kreport.com/methodology