FDA UDI
In Commercial Distribution
🇺🇸 United States
Radiance
DI: 08436567540024
·
Model: 5
·
GMV SOLUCIONES GLOBALES INTERNET SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Radiance
- Primary DI
- 08436567540024
- Version / Model
- 5
- Company Name
- GMV SOLUCIONES GLOBALES INTERNET SA
- Labeler DUNS
- 462279436
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-08
- Public Version
- 1
- Public Version Date
- 2026-04-16
- Public Version Status
- New
- Public Device Record Key
- caf70567-4427-438b-bb88-4b24c7cf63ad
Device Description
Radiance V5 is a software system intended for treatment planning and analysis of radiation therapy administered with devicessuitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dosedistributions expected during the proposed treatment, and may be used to administer treatments after review and approval by theintended user. The system functionality can be configured based on use
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40887 | Radiation therapy software | An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08436567540024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233236 | 000 |