Icobrain
System, Image Processing, Radiological
Icometrix
The following data is part of a premarket notification filed by Icometrix with the FDA for Icobrain.
Pre-market Notification Details
| Device ID | K180326 |
| 510k Number | K180326 |
| Device Name: | Icobrain |
| Classification | System, Image Processing, Radiological |
| Applicant | icometrix Kolonel Begaultlaan 1b /12 Leuven, BE 3012 |
| Contact | Dirk Smeets |
| Correspondent | Dirk Smeets icometrix Kolonel Begaultlaan 1b /12 Leuven, BE 3012 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-06 |
| Decision Date | 2018-03-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B621ICOBRAIN30 | K180326 | 000 |
Trademark Results [Icobrain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICOBRAIN 79271848 not registered Live/Pending |
icoMetrix 2019-09-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.