VBrain
Radiological Image Processing Software For Radiation Therapy
Vysioneer Inc.
The following data is part of a premarket notification filed by Vysioneer Inc. with the FDA for Vbrain.
Pre-market Notification Details
| Device ID | K213628 |
| 510k Number | K213628 |
| Device Name: | VBrain |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | Vysioneer Inc. 33 Rogers. St., # 308 Cambridge, MA 02142 |
| Contact | Vicki Lin |
| Correspondent | Vicki Lin Vysioneer Inc. 33 Rogers. St., # 308 Cambridge, MA 02142 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-17 |
| Decision Date | 2021-12-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719884900011 | K213628 | 000 |
Trademark Results [VBrain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VBRAIN 88652425 not registered Live/Pending |
Vysioneer Inc. 2019-10-12 |
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