The following data is part of a premarket notification filed by Vysioneer Inc. with the FDA for Vbrain.
| Device ID | K203235 |
| 510k Number | K203235 |
| Device Name: | VBrain |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | Vysioneer Inc. 33 Rogers. St., # 308 Cambridge, MA 02142 |
| Contact | Jeni-tang Lu |
| Correspondent | Chiu S Lin Vysioneer Inc. 33 Rogers. St., # 308 Cambridge, MA 02142 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-03 |
| Decision Date | 2021-03-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VBRAIN 88652425 not registered Live/Pending |
Vysioneer Inc. 2019-10-12 |