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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 K030781
Device Name KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
Applicant
Eastman Kodak Company
47315 Mission Falls Ct.
Fremont,  CA  94539
Applicant Contact LINDA J MOORE
Correspondent
Eastman Kodak Company
47315 Mission Falls Ct.
Fremont,  CA  94539
Correspondent Contact LINDA J MOORE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/11/2003
Decision Date 05/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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