Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K192130 |
Device Name |
Icobrain |
Applicant |
Icometrix NV |
Kolonel Begaultlaan 1b/12 |
Leuven,
BE
3012
|
|
Applicant Contact |
Dirk Smeets |
Correspondent |
Icometrix NV |
Kolonel Begaultlaan 1b/12 |
Leuven,
BE
3012
|
|
Correspondent Contact |
Dirk Smeets |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/07/2019 |
Decision Date | 12/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|