De Novo DEN220014
- Device
- RefleXion Medical Radiotherapy System (RMRS)
- Contact
- kathy o'shaughnessy
- De Novo number
- DEN220014
- Product code
- QVA
- Regulation
- 892.5060
- Classification name
- fludeoxyglucose f18-guided radiation therapy system
- Decision
- granted (DENG)
- Decision date
- 2023-02-01
- Date received
- 2022-02-23
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QVA
- Device name
- Fludeoxyglucose F18-Guided Radiation Therapy System
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.5060
- Implant
- N
- Life sustain/support
- N