LumenCare Azure
Device Facts
| Record ID | K262383 |
|---|---|
| Device Name | LumenCare Azure |
| Applicant | Nucletron B.V. |
| Product Code | JAQ · Radiology |
| Decision Date | Jul 24, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.5700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
