Identity
- Trade Name
- radiance FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Radiance V3 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 V3 shall be clinically qualified radiation therapy staff trained in using the system. FDA UDI
- Model / Reference
- 3 FDA UDI
- Description
- Radiance V3 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 V3 shall be clinically qualified radiation therapy staff trained in using the system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436567540000 FDA UDI
- 510(k) Number
- K153368 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiation therapy software
radiance by Gmv Soluciones Globales Internet Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gmv Soluciones Globales Internet Sa
Sources (1)
- FDA UDI 2a7ca56f-643f-4b3e-8597-2a8c928f8968 34 fields · synced May 30, 2026