Home / Device Classification / EAM

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
K943822fujifilm medical system u.s.aFUJI UM MAMMO SERIES INTENSIFY SCREENS:August 22, 1994
K943823fujifilm medical system u.s.aFUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12August 22, 1994
K943821fujifilm medical system u.s.aKYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECAugust 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
K942805fujifilm medical system u.s.aKYOKKO BLUE SERIES INTENSIFYING SCREENSJuly 29, 1994
K942909eastman kodakKODAK INSIGHT TWIN-LOAD INSERTJuly 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
K920200e.i. dupont de nemours and coULTRA-VISION DETAIL INTENSIFYING SCREENMay 28, 1992
K920190e.i. dupont de nemours and coULTRA-VISION RAPID 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