Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K113599 |
Device Name |
SURGICASE CONNECT |
Applicant |
MATERIALISE N.V. |
TECHNOLOGIELAAN 15 |
LEUVEN,
BE
3001
|
|
Applicant Contact |
Alexandra Razzhivina |
Correspondent |
MATERIALISE N.V. |
TECHNOLOGIELAAN 15 |
LEUVEN,
BE
3001
|
|
Correspondent Contact |
Alexandra Razzhivina |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/05/2011 |
Decision Date | 04/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|