Digirad Corp. - FDA 510(k) Cleared Devices
Recent clearances: ERGO IMAGING SYSTEM, ERGO IMAGING SYSTEM, CARDIUS 3 X-ACT
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Digirad Corp. Radiology ✕
16 devices
Cleared
Jan 15, 2013
ERGO IMAGING SYSTEM
Radiology
71d
Cleared
Apr 23, 2010
ERGO IMAGING SYSTEM
Radiology
30d
Cleared
Mar 09, 2009
CARDIUS 3 X-ACT
Radiology
90d
Cleared
Dec 17, 2008
STASYS MOTION CORRECTION SOFTWARE
Radiology
78d
Cleared
Sep 12, 2008
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT...
Radiology
25d
Cleared
Mar 23, 2007
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
Radiology
25d
Cleared
Oct 04, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
Radiology
28d
Cleared
Jul 13, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
Radiology
30d
Cleared
Feb 05, 2003
CARDIUS-1 AND CARDIS-2
Radiology
27d
Cleared
Nov 22, 2002
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
Radiology
64d
Cleared
Jun 15, 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
Radiology
25d
Cleared
Nov 04, 1998
DIGIRAD 2020TC SPECT IMAGING SYSTEM
Radiology
90d