QBRAIN
System, Image Processing, Radiological
MEDIS MEDICAL IMAGING SYSTEMS, B.V.
The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Qbrain.
Pre-market Notification Details
| Device ID | K050703 |
| 510k Number | K050703 |
| Device Name: | QBRAIN |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. Schuttersveld 9 Leiden, NL 2316 Xg |
| Contact | J.i. Hollander |
| Correspondent | J.i. Hollander MEDIS MEDICAL IMAGING SYSTEMS, B.V. Schuttersveld 9 Leiden, NL 2316 Xg |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-04-21 |
| Summary: | summary |
Trademark Results [QBRAIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QBRAIN 86122422 4571417 Live/Registered |
The Executor of the Andrew M. Gold Estate 2013-11-19 |
 QBRAIN 79009587 3130013 Dead/Cancelled |
Medis Medical Imaging Systems bv 2005-02-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.