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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K211720
Device Name Planmed Clarity 2D, Planmed Clarify S
Applicant
Planmed OY
Sorvaajankatu 7
Helsinki,  FI 00880
Applicant Contact Niina Vuorikallas
Correspondent
Planmed OY
Sorvaajankatu 7
Helsinki,  FI 00880
Correspondent Contact Niina Vuorikallas
Regulation Number892.1715
Classification Product Code
MUE  
Date Received06/04/2021
Decision Date 07/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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