Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K192317 |
Device Name |
Planmed Clarity 2D and Clarity S |
Applicant |
Planmed Oy |
Sorvaajankatu 7 |
Helsinki,
FI
00880
|
|
Applicant Contact |
Lars Moring |
Correspondent |
Planmed Oy |
Sorvaajankatu 7 |
Helsinki,
FI
00880
|
|
Correspondent Contact |
Lars Moring |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 08/26/2019 |
Decision Date | 10/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|