The following data is part of a premarket notification filed by Icometrix Nv with the FDA for Icobrain.
Device ID | K181939 |
510k Number | K181939 |
Device Name: | Icobrain |
Classification | System, Image Processing, Radiological |
Applicant | icometrix NV Kolonel Begaultlaan 1b/12 Leuven, BE 3012 |
Contact | Jan Verheyden |
Correspondent | Jan Verheyden icometrix NV Kolonel Begaultlaan 1b/12 Leuven, BE 3012 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-19 |
Decision Date | 2018-11-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ICOBRAIN 79271848 not registered Live/Pending |
icoMetrix 2019-09-16 |