Device Classification Name |
system, x-ray, extraoral source, digital
|
510(k) Number |
K191719 |
Device Name |
X-MIND Trium |
Applicant |
de Gotzen S.R.L |
via Roma, 45 |
Olgiate Olona,
IT
21057
|
|
Applicant Contact |
Dario Bandiera |
Correspondent |
de Gotzen S.R.L |
via Roma, 45 |
Olgiate Olona,
IT
21057
|
|
Correspondent Contact |
Dario Bandiera |
Regulation Number | 872.1800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2019 |
Decision Date | 02/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|