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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 K023772
Device Name KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Applicant
Acuson Corp.
1230 Shorebird Way
Mountainview,  CA  94043
Applicant Contact BOB LEIKER
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/12/2002
Decision Date 11/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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