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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 K864927
Device Name KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact NORMAN H GEIL
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact NORMAN H GEIL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/04/1986
Decision Date 02/11/1987
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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