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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K042868
Device Name MAMMOREPORT SOFTCOPY WORKSTATION
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact DEBRA PEACOCK
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact DEBRA PEACOCK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/18/2004
Decision Date 01/06/2005
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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