Device Classification Name |
Analyzer, Medical Image
|
510(k) Number |
K231678 |
Device Name |
Overjet Periapical Radiolucency Assist |
Applicant |
Overjet, Inc |
560 Harrison Ave #403 |
Boston,
MA
02118
|
|
Applicant Contact |
Deepthi Paknikar |
Correspondent |
Overjet, Inc |
560 Harrison Ave #403 |
Boston,
MA
02118
|
|
Correspondent Contact |
Deepthi Paknikar |
Regulation Number | 892.2070
|
Classification Product Code |
|
Date Received | 06/09/2023 |
Decision Date | 09/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|