Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K202256 |
Device Name |
3Shape Implant Studio |
Applicant |
3Shape Medical A/S |
Holmens Kanal 7 |
Copenhagen,
DK
DK-1060
|
|
Applicant Contact |
Jenny Axel |
Correspondent |
Accelerated Device Approval Services |
6800 S.W. 40th Street, Ste. 403 |
Ludlum,
FL
33155
|
|
Correspondent Contact |
Rafael Aguila |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/10/2020 |
Decision Date | 09/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|