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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 K022896
Device Name CSV12 SOFTWARE VIEWER
Applicant
ACUSON CORP.
1220 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94039 -7393
Applicant Contact BOB LEIKER
Correspondent
ACUSON CORP.
1220 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94039 -7393
Correspondent Contact BOB LEIKER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/03/2002
Decision Date 10/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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