DEN220017 is an FDA 510(k) submission for the BioXmark. This device is classified as a Phase-changing Fiducial Marker For Radiation Therapy (Class II - Special Controls, product code QUV).
Submitted by Nanovi A/S (Kgs. Lyngby, DK). The FDA issued a Not Cleared (DENG) decision on December 23, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5727. A Phase-changing Fiducial Marker For Radiation Therapy Is A Single-use, Sterile Liquid Material That Changes Phase In Situ When Injected In Tissue For The Purposes Of Aiding Radiation Therapy Treatment. The Device Is Intended To Be Visualized Using One Or More Radiologic Imaging Modalities..
| 510(k) Number | DEN220017 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 04, 2022 |
| Decision Date | December 23, 2022 |
| Days to Decision | 294 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | QUV - Phase-changing Fiducial Marker For Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5727 |
| Definition | A Phase-changing Fiducial Marker For Radiation Therapy Is A Single-use, Sterile Liquid Material That Changes Phase In Situ When Injected In Tissue For The Purposes Of Aiding Radiation Therapy Treatment. The Device Is Intended To Be Visualized Using One Or More Radiologic Imaging Modalities. |