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Digirad Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K123408ERGO IMAGING SYSTEMJanuary 15, 2013
K100838ERGO IMAGING SYSTEMApril 23, 2010
K083649CARDIUS 3 X-ACTMarch 9, 2009
K082904STASYS MOTION CORRECTION SOFTWAREDecember 17, 2008
K082368CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEMSeptember 12, 2008
K070542CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMSMarch 23, 2007
K052430CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEMOctober 4, 2005
K051549CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEMJuly 13, 2005
K030085CARDIUS-1 AND CARDIS-2February 5, 2003
K023110CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005November 22, 2002
K011572QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)June 15, 2001
K982855DIGIRAD 2020TC SPECT IMAGING SYSTEMNovember 4, 1998
K961104NOTEBOOK IMAGERMay 28, 1997
K854407DIGIRAD REUSABLE IMAGE MEDIAMarch 10, 1986
K852284DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIANovember 14, 1985
K828562DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTEApril 28, 1983