The following data is part of a premarket notification filed by Icometrix Nv with the FDA for Icobrain-ctp.
| Device ID | K192962 |
| 510k Number | K192962 |
| Device Name: | Icobrain-ctp |
| Classification | System, Image Processing, Radiological |
| Applicant | Icometrix NV Kolonel Begaultlaan 1b/12 Leuven, BE 3012 |
| Contact | Dirk Smeets |
| Correspondent | Dirk Smeets 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 | 2019-10-22 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B621ICOBRAINCTP10 | K192962 | 000 |