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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 K192317
Device Name Planmed Clarity 2D and Clarity S
Planmed Oy
Sorvaajankatu 7
Helsinki,  FI 00880
Applicant Contact Lars Moring
Planmed Oy
Sorvaajankatu 7
Helsinki,  FI 00880
Correspondent Contact Lars Moring
Regulation Number892.1715
Classification Product Code
Date Received08/26/2019
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