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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 K041029
Device Name KINETDX
Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
400 W. MORGAN ROAD
ANN ARBOR,  MI  48108
Applicant Contact ANA LADINO
Correspondent
SIEMENS MEDICAL SOLUTIONS, INC.
400 W. MORGAN ROAD
ANN ARBOR,  MI  48108
Correspondent Contact ANA LADINO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/21/2004
Decision Date 07/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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