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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K051483
Device Name KODAK DIRECTVIEW DR SYSTEM DETECTOR
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Applicant Contact CHRISTINE E EHMANN
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Correspondent Contact CHRISTINE E EHMANN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/06/2005
Decision Date 06/21/2005
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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