Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K162008 |
Device Name |
JiveX |
Applicant |
VISUS TECHNOLOGY TRANSFER GMBH |
Universitaetsstrasse 136 |
bochum,
DE
44799
|
|
Applicant Contact |
axel schreiber |
Correspondent |
VISUS TECHNOLOGY TRANSFER GMBH |
Universitaetsstrasse 136 |
bochum,
DE
44799
|
|
Correspondent Contact |
axel schreiber |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/20/2016 |
Decision Date | 09/16/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|