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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 K121963
Device Name PLANMED NUANCE DIGIGUIDE
Applicant
Planmed OY
Asentajankatu 6
Sorvaajankatu 7
Helsinki,  FI FI-00880
Applicant Contact LARS MORING
Correspondent
Planmed OY
Asentajankatu 6
Sorvaajankatu 7
Helsinki,  FI FI-00880
Correspondent Contact LARS MORING
Regulation Number892.1715
Classification Product Code
MUE  
Date Received07/05/2012
Decision Date 11/21/2012
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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