Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K170419 |
Device Name |
SurgiCase Viewer |
Applicant |
Materialise NV |
Technologielaan 15 |
leuven,
BE
3001
|
|
Applicant Contact |
oliver clemens |
Correspondent |
Materialise NV |
Technologielaan 15 |
leuven,
BE
3001
|
|
Correspondent Contact |
oliver clemens |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/13/2017 |
Decision Date | 05/11/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|