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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 K033624
Device Name PACS SOFTWARE SOLUTION 2003
Applicant
Canon USA, Inc.
16787 Bernardo Center Dr.
Suite A1
San Diego,  CA  92128
Applicant Contact SEAN M CURRY
Correspondent
Canon USA, Inc.
16787 Bernardo Center Dr.
Suite A1
San Diego,  CA  92128
Correspondent Contact SEAN M CURRY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/18/2003
Decision Date 12/15/2003
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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