Device Classification Name |
phase-changing fiducial marker for radiation therapy
|
De Novo Number |
DEN220017 |
Device Name |
BioXmark |
Requester |
Nanovi A/S |
diplomvej 378 |
kgs. lyngby,
DK
2800
|
|
Contact |
hsiao-qing chow |
|
Regulation Number | 892.5727
|
Classification Product Code |
|
Date Received | 03/04/2022 |
Decision Date | 12/23/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Radiology
|
Review Advisory Committee |
Radiology
|
Reclassification Order |
Reclassification Order
|
Type |
Direct
|
|
|