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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K792123
Device Name KODAK LANEX MED. SCREEN
Applicant
Eastman Kodak Company
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Eastman Kodak Company
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1960
Classification Product Code
EAM  
Date Received10/25/1979
Decision Date 12/10/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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