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De Novo DEN220017
- Device
- BioXmark
- Contact
- hsiao-qing chow
- De Novo number
- DEN220017
- Product code
- QUV
- Regulation
- 892.5727
- Classification name
- phase-changing fiducial marker for radiation therapy
- Decision
- granted (DENG)
- Decision date
- 2022-12-23
- Date received
- 2022-03-04
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QUV
- Device name
- Phase-Changing Fiducial Marker For Radiation Therapy
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.5727
- Implant
- Y
- Life sustain/support
- N