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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K904953
Device Name PLANMED SOPHIE
Applicant
Planmeca USA, Inc.
Asentajasnkatu 6
00810 Helsinki
Finland,  FI
Applicant Contact MATTI SPOLANDER
Correspondent
Planmeca USA, Inc.
Asentajasnkatu 6
00810 Helsinki
Finland,  FI
Correspondent Contact MATTI SPOLANDER
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/05/1990
Decision Date 04/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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