EAM · Class I · 21 CFR 892.1960

FDA Product Code EAM: Screen, Intensifying, Radiographic

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Eastman Kodak Company and Fujifilm Medical System U.S.A., Inc..

35
Total
35
Cleared
76d
Avg days
1977
Since

FDA 510(k) Cleared Screen, Intensifying, Radiographic Devices (Product Code EAM)

35 devices
1–24 of 35
Cleared Aug 22, 1994
KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
K943821
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 22, 1994
FUJI UM MAMMO SERIES INTENSIFY SCREENS:
K943822
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 22, 1994
FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12
K943823
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 17, 1994
KYOKKO GREEN SERIES INTENSIFYING SCREENS
K942235
Fujifilm Medical System U.S.A., Inc.
Radiology · 100d
Cleared Aug 17, 1994
FUJI HG-M INTENSIFYING SCREEN
K943425
Fujifilm Medical System U.S.A., Inc.
Radiology · 33d
Cleared Jul 29, 1994
KYOKKO BLUE SERIES INTENSIFYING SCREENS
K942805
Fujifilm Medical System U.S.A., Inc.
Radiology · 44d
Cleared Jul 29, 1994
KODAK INSIGHT TWIN-LOAD INSERT
K942909
Eastman Kodak Company
Radiology · 38d
Cleared Jun 10, 1994
KYOKKO UM SERIES INTENSIFYING SCREEN
K942399
Fujifilm Medical System U.S.A., Inc.
Radiology · 22d
Cleared Oct 07, 1993
ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN
K933161
Dupont Medical Products
Radiology · 100d
Cleared Jun 08, 1993
MICROVISION FAST DETAIL INTENSIFYING SCREEN
K931283
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 88d
Cleared May 28, 1992
ULTRA-VISION RAPID INTENSIFYING SCREEN
K920190
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 134d
Cleared May 28, 1992
ULTRA-VISION DETAIL INTENSIFYING SCREEN
K920200
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 134d
Cleared May 27, 1992
ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN
K920194
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 133d
Cleared Feb 16, 1990
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN
K900448
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 24d
Cleared Feb 05, 1990
CRONEX QUANTA SR300 INTENSIFYING SCREEN
K900103
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 27d
Cleared Feb 05, 1990
CRONEX QUANTA SUPER RAPID SR339 RARE EARTH
K900318
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 13d
Cleared Jun 23, 1989
CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN
K893510
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 49d
Cleared Aug 27, 1987
KODAK MIN-R MEDIUM SCREEN
K873167
Eastman Kodak Company
Radiology · 16d
Cleared Mar 06, 1986
KODAK MIN-R FAST SCREEN SO-459
K860755
Eastman Kodak Company
Radiology · 6d
Cleared Feb 26, 1985
CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS
K845030
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 61d
Cleared Feb 21, 1984
CRONEX SR-337
K834484
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 82d
Cleared Dec 14, 1981
KODAK INTENSIFYING SCREEN 80-175
K813147
Eastman Kodak Company
Radiology · 38d
Cleared Dec 08, 1981
KODAK INTENSIFYING SCREEN SO-168
K813139
Eastman Kodak Company
Radiology · 32d
Cleared Dec 10, 1979
KODAK LANEX MED. SCREEN
K792123
Eastman Kodak Company
Radiology · 46d

About Product Code EAM - Regulatory Context