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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
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