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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, Mobile
510(k) Number K071015
Device Name OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
J-15
Malvern,  PA  19355
Applicant Contact KIMBERLY RENDON
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
J-15
Malvern,  PA  19355
Correspondent Contact KIMBERLY RENDON
Regulation Number892.1720
Classification Product Code
IZL  
Date Received04/10/2007
Decision Date 05/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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