Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K213302 |
Device Name |
exoplan |
Applicant |
exocad GmbH |
37, Julius-Reiber-Str. |
Darmstadt,
DE
64293
|
|
Applicant Contact |
Tobias Turba |
Correspondent |
exocad GmbH |
37, Julius-Reiber-Str. |
Darmstadt,
DE
64293
|
|
Correspondent Contact |
Tobias Turba |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/04/2021 |
Decision Date | 05/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|