The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Qbrain.
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 |
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 |