Eigen - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Eigen has 16 FDA 510(k) cleared radiology devices. Based in Nevada City, US.
Last cleared in 2023. Active since 1988.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
16 devices
Cleared
Oct 12, 2023
Artemis, Artemis TPO, Artemis MX
Radiology
444d
Cleared
Nov 21, 2018
ProFuse CAD
Radiology
349d
Cleared
Oct 21, 2016
Artemis
Radiology
45d
Cleared
Jan 26, 2007
EIGEN DSA 2000
Radiology
30d
Cleared
Apr 07, 1994
DIGITAL DISK RECORDER
Radiology
286d
Cleared
Nov 23, 1992
DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT
Radiology
96d
Cleared
Oct 21, 1992
DIGITAL FLUORO STORE
Radiology
93d
Cleared
Sep 23, 1991
DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES
Radiology
77d
Cleared
Jan 25, 1991
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
Radiology
73d
Cleared
Nov 07, 1990
PSC-1 W/OTHER NUMERICAL
Radiology
79d
Cleared
Aug 03, 1990
DIGITAL PHOTOSPOT
Radiology
31d
Cleared
Jul 02, 1990
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
Radiology
62d
Cleared
Mar 14, 1989
SC-1000 WITH SUFFIXES (SCAN CONVERTER)
Radiology
29d
Cleared
Aug 19, 1988
HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP
Radiology
87d
Cleared
Aug 11, 1988
VTR-12
Radiology
79d
Cleared
Jun 28, 1988
HR-1000 W/SUFFIXES (B,C OR D)
Radiology
35d