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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Film Marking, Radiographic
510(k) Number K920031
Device Name KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact MILAGROS MONTES
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact MILAGROS MONTES
Regulation Number892.1640
Classification Product Code
JAC  
Date Received01/03/1992
Decision Date 02/12/1992
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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