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EAM — Screen, Intensifying, Radiographic Class I

FDA Device Classification

Classification Details

Product Code
EAM
Device Class
Class I
Regulation Number
892.1960
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K974423sterling diagnostic imagingULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILDecember 22, 1997
K963913konica medicalMD100 & MM150October 8, 1997
K954161jpi healthcare coJPI INTENSIFYING SCREENFebruary 2, 1996
K943821fujifilm medical system u.s.aKYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECAugust 22, 1994
K943823fujifilm medical system u.s.aFUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12August 22, 1994
K943822fujifilm medical system u.s.aFUJI UM MAMMO SERIES INTENSIFY SCREENS:August 22, 1994
K943425fujifilm medical system u.s.aFUJI HG-M INTENSIFYING SCREENAugust 17, 1994
K942235fujifilm medical system u.s.aKYOKKO GREEN SERIES INTENSIFYING SCREENSAugust 17, 1994
K942909eastman kodakKODAK INSIGHT TWIN-LOAD INSERTJuly 29, 1994
K942805fujifilm medical system u.s.aKYOKKO BLUE SERIES INTENSIFYING SCREENSJuly 29, 1994
K942399fujifilm medical system u.s.aKYOKKO UM SERIES INTENSIFYING SCREENJune 10, 1994
K941023mci optonixRAREX GREEN FASTMarch 30, 1994
K933161dupont medical productsULTRA-VISION SUPER RAPID INTENSIFYING SCREENOctober 7, 1993
K931283e.i. dupont de nemours and coMICROVISION FAST DETAIL INTENSIFYING SCREENJune 8, 1993
K920190e.i. dupont de nemours and coULTRA-VISION RAPID INTENSIFYING SCREENMay 28, 1992
K920200e.i. dupont de nemours and coULTRA-VISION DETAIL INTENSIFYING SCREENMay 28, 1992
K920194e.i. dupont de nemours and coULTRA-VISION FAST DETAIL INTENSIFYING SCREENMay 27, 1992
K896707perlink usaPERLINK SCREEN, KIRAN SCREENAugust 30, 1990
K902039mci optonixRAREX & OPTEX X-RAY SCREENSJuly 27, 1990
K901014infabRADIOGRAPHIC INTENSIFYING SCREENApril 2, 1990