FDA 510(k) Applications for Medical Device Product Code "EAM"
(Screen, Intensifying, Radiographic)

FDA 510(k) Number Applicant Device Name Decision Date
K933161 DUPONT MEDICAL PRODUCTS ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN 10/07/1993
K770574 E.I. DUPONT DE NEMOURS & CO., INC. CRONEX QUANTA III INTENSIFYING SCREENS 04/05/1977
K900448 E.I. DUPONT DE NEMOURS & CO., INC. CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN 02/16/1990
K900103 E.I. DUPONT DE NEMOURS & CO., INC. CRONEX QUANTA SR300 INTENSIFYING SCREEN 02/05/1990
K900318 E.I. DUPONT DE NEMOURS & CO., INC. CRONEX QUANTA SUPER RAPID SR339 RARE EARTH 02/05/1990
K893510 E.I. DUPONT DE NEMOURS & CO., INC. CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN 06/23/1989
K834484 E.I. DUPONT DE NEMOURS & CO., INC. CRONEX SR-337 02/21/1984
K845030 E.I. DUPONT DE NEMOURS & CO., INC. CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS 02/26/1985
K931283 E.I. DUPONT DE NEMOURS & CO., INC. MICROVISION FAST DETAIL INTENSIFYING SCREEN 06/08/1993
K920200 E.I. DUPONT DE NEMOURS & CO., INC. ULTRA-VISION DETAIL INTENSIFYING SCREEN 05/28/1992
K920194 E.I. DUPONT DE NEMOURS & CO., INC. ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN 05/27/1992
K920190 E.I. DUPONT DE NEMOURS & CO., INC. ULTRA-VISION RAPID INTENSIFYING SCREEN 05/28/1992
K942909 EASTMAN KODAK COMPANY KODAK INSIGHT TWIN-LOAD INSERT 07/29/1994
K813147 EASTMAN KODAK COMPANY KODAK INTENSIFYING SCREEN 80-175 12/14/1981
K813139 EASTMAN KODAK COMPANY KODAK INTENSIFYING SCREEN SO-168 12/08/1981
K792123 EASTMAN KODAK COMPANY KODAK LANEX MED. SCREEN 12/10/1979
K860755 EASTMAN KODAK COMPANY KODAK MIN-R FAST SCREEN SO-459 03/06/1986
K873167 EASTMAN KODAK COMPANY KODAK MIN-R MEDIUM SCREEN 08/27/1987
K770837 EASTMAN KODAK COMPANY SCREEN, FINE, LANES, KODAK 05/26/1977
K943823 FUJIFILM MEDICAL SYSTEM U.S.A., INC. FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 08/22/1994
K943425 FUJIFILM MEDICAL SYSTEM U.S.A., INC. FUJI HG-M INTENSIFYING SCREEN 08/17/1994
K943822 FUJIFILM MEDICAL SYSTEM U.S.A., INC. FUJI UM MAMMO SERIES INTENSIFY SCREENS: 08/22/1994
K942805 FUJIFILM MEDICAL SYSTEM U.S.A., INC. KYOKKO BLUE SERIES INTENSIFYING SCREENS 07/29/1994
K942235 FUJIFILM MEDICAL SYSTEM U.S.A., INC. KYOKKO GREEN SERIES INTENSIFYING SCREENS 08/17/1994
K943821 FUJIFILM MEDICAL SYSTEM U.S.A., INC. KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC 08/22/1994
K942399 FUJIFILM MEDICAL SYSTEM U.S.A., INC. KYOKKO UM SERIES INTENSIFYING SCREEN 06/10/1994
K770094 GENERAL ELECTRIC CO. FLUORICON 500 IMAGE INTENSIFIERS 01/21/1977
K901014 INFAB CORP. RADIOGRAPHIC INTENSIFYING SCREEN 04/02/1990
K954161 JPI HEALTHCARE CO., LTD JPI INTENSIFYING SCREEN 02/02/1996
K963913 KONICA MEDICAL CORP. MD100 & MM150 10/08/1997
K902039 MCI OPTONIX, INC. RAREX & OPTEX X-RAY SCREENS 07/27/1990
K941023 MCI OPTONIX, INC. RAREX GREEN FAST 03/30/1994
K862414 PAREXEL INTL. CORP. FUJI CR IMAGING PLATE 02/26/1987
K896707 PERLINK USA, INC. PERLINK SCREEN, KIRAN SCREEN 08/30/1990
K974423 STERLING DIAGNOSTIC IMAGING, INC. ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL 12/22/1997


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