Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K171356 |
Device Name |
Clarity Reveal |
Applicant |
Ceevra, Inc. |
3960 Franke Ln. |
lafayette,
CA
94549
|
|
Applicant Contact |
russ yoshinaka |
Correspondent |
Ceevra, Inc. |
3960 Franke Ln. |
lafayette,
CA
94549
|
|
Correspondent Contact |
russ yoshinaka |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/09/2017 |
Decision Date | 08/03/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|