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 |