Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K192743 |
Device Name |
VisionX 2.4 |
Applicant |
Durr Dental SE |
Hopfigheimer Str. 17 |
Bietigheim-Bissingen,
DE
74321
|
|
Applicant Contact |
Oliver Lange |
Correspondent |
Kamm & Associates |
8870 Ravello Ct |
Naples,
FL
34114
|
|
Correspondent Contact |
Daniel Kamm |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/30/2019 |
Decision Date | 10/31/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|