Eigen

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K222222Artemis, Artemis TPO, Artemis MXOctober 12, 2023
K173744ProFuse CADNovember 21, 2018
K162474ArtemisOctober 21, 2016
K082341DSA 2000EXAugust 29, 2008
K0810933-D IMAGING WORKSTATIONMay 1, 2008
K063846EIGEN DSA 2000January 26, 2007
K933115DIGITAL DISK RECORDERApril 7, 1994
K924164DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPTNovember 23, 1992
K923585DIGITAL FLUORO STOREOctober 21, 1992
K913012DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXESSeptember 23, 1991
K905111DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXESJanuary 25, 1991
K903821PSC-1 W/OTHER NUMERICALNovember 7, 1990
K902927DIGITAL PHOTOSPOTAugust 3, 1990
K901956DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)July 2, 1990
K890745SC-1000 WITH SUFFIXES (SCAN CONVERTER)March 14, 1989
K882175HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVPAugust 19, 1988
K882176VTR-12August 11, 1988
K882184HR-1000 W/SUFFIXES (B,C OR D)June 28, 1988