510(k) DEN220017
- Device
- BioXmark
- Applicant
- Nanovi A/S
- 510(k) number
- DEN220017
- Product code
- QUV
- Decision
- Unknown (DENG)
- Decision date
- 2022-12-23
- Date received
- 2022-03-04
- Regulation
- 892.5727
- Classification name
- Phase-Changing Fiducial Marker For Radiation Therapy
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hsiao-Qing Chow
- Address
- Diplomvej 378 Kgs. Lyngby DK 2800 2800
FDA Registration Numbers#
- 9614559
- 1932738
Source Documents#
510(k) summary PDF not indicated by FDA