Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K200703 |
Device Name |
JiveX |
Applicant |
Visus Health IT GmbH |
Gesundheitscampus-Sued 15-17 |
Bochum,
DE
44801
|
|
Applicant Contact |
Axel Schreiber |
Correspondent |
Visus Health IT GmbH |
Gesundheitscampus-Sued 15-17 |
Bochum,
DE
44801
|
|
Correspondent Contact |
Axel Schreiber |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/18/2020 |
Decision Date | 04/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|