Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K183458 |
Device Name |
exoplan 2.3 |
Applicant |
exocad GmbH |
37, Julius-Reiber-Str. |
Darmstadt,
DE
64293
|
|
Applicant Contact |
Stefan Walter |
Correspondent |
exocad GmbH |
37, Julius-Reiber-Str. |
Darmstadt,
DE
64293
|
|
Correspondent Contact |
Stefan Walter |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/13/2018 |
Decision Date | 08/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|