Radiance V5 Radiation Therapy Planning System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233236 FDA 510(k)
- FDA Product Code
- MUJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Radiance V5 is a Radiation Therapy Treatment Planning System, designed for precise calculation and optimization of radiation dose distributions in external beam radiotherapy. It integrates advanced algorithms to simulate treatment plans, ensuring accurate targeting of malignant tissues while minimizing exposure to healthy surrounding tissue.
This system is supplied as a software solution for use in radiation oncology departments, typically integrated into existing treatment workflows. It operates on compatible workstations and requires no sterility considerations, as it is non-invasive and non-disposable. The device is classified under FDA device class 2 and has received FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for radiation therapy planning equipment.
Frequently asked questions
What is the primary purpose of the Radiance V5 in a radiation oncology workflow?
The Radiance V5 is a Radiation Therapy Treatment Planning System designed to calculate and optimize radiation dose distributions for external beam radiotherapy. It uses advanced algorithms to simulate treatment plans, ensuring precise targeting of malignant tissues while sparing healthy surrounding tissue. This software integrates into existing workflows to enhance accuracy and efficiency in radiation treatment planning.
Is the Radiance V5 a single-use or reusable device, and are there any sterility requirements?
The Radiance V5 is a software-based solution and is not a physical, disposable, or reusable medical device. Since it operates on compatible workstations and does not involve direct patient contact or invasive procedures, there are no sterility requirements or concerns. It is intended for repeated use within radiation oncology departments.
What regulatory approvals does the Radiance V5 hold, and how does this affect its use?
The Radiance V5 has received FDA 510(k) clearance and MDR authorization, confirming compliance with regulatory standards for radiation therapy planning systems. These approvals validate its safety and effectiveness for use in external beam radiotherapy treatment planning, ensuring it meets the necessary requirements for clinical implementation in radiation oncology departments.
How is the Radiance V5 supplied, and what system requirements are necessary for its operation?
The Radiance V5 is supplied as a software solution and requires installation on compatible workstations within radiation oncology departments. Since it is not a standalone hardware device, it must be integrated into existing treatment planning systems and workflows. No additional physical components or sterility considerations are required, as it operates entirely digitally.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233236 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gmv Soluciones Globales Internet S.A.U.
Sources (2)
- FDA 510(k) K233236 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026