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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 K040970
Device Name LEONARDO
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355 -1406
Applicant Contact ANA LADINO
Correspondent
SIEMENS MEDICAL SYSTEMS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355 -1406
Correspondent Contact ANA LADINO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/14/2004
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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