Device Classification Name |
Analyzer, Medical Image
|
510(k) Number |
K213795 |
Device Name |
Videa Caries Assist |
Applicant |
VideaHealth, Inc |
19 Kingston St |
Boston,
MA
02111
|
|
Applicant Contact |
Florian Hillen |
Correspondent |
Biologics Consulting |
1555 King St, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Donna-Bea Tillman |
Regulation Number | 892.2070
|
Classification Product Code |
|
Date Received | 12/06/2021 |
Decision Date | 04/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|