Medical Device Manufacturer · US , Palo Alto , CA

Digirad Corp. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1983
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Digirad Corp. Radiology
16 devices
1-16 of 16
Cleared Jan 15, 2013
ERGO IMAGING SYSTEM
K123408 · IYX
Radiology · 71d
Cleared Apr 23, 2010
ERGO IMAGING SYSTEM
K100838 · IYX
Radiology · 30d
Cleared Mar 09, 2009
CARDIUS 3 X-ACT
K083649 · KPS
Radiology · 90d
Cleared Dec 17, 2008
STASYS MOTION CORRECTION SOFTWARE
K082904 · KPS
Radiology · 78d
Cleared Sep 12, 2008
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT...
K082368 · KPS
Radiology · 25d
Cleared Mar 23, 2007
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
K070542 · KPS
Radiology · 25d
Cleared Oct 04, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K052430 · KPS
Radiology · 28d
Cleared Jul 13, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K051549 · KPS
Radiology · 30d
Cleared Feb 05, 2003
CARDIUS-1 AND CARDIS-2
K030085 · KPS
Radiology · 27d
Cleared Nov 22, 2002
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
K023110 · KPS
Radiology · 64d
Cleared Jun 15, 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · KPS
Radiology · 25d
Cleared Nov 04, 1998
DIGIRAD 2020TC SPECT IMAGING SYSTEM
K982855 · KPS
Radiology · 90d
Cleared May 28, 1997
NOTEBOOK IMAGER
K961104 · IYX
Radiology · 434d
Cleared Mar 10, 1986
DIGIRAD REUSABLE IMAGE MEDIA
K854407 · LQA
Radiology · 129d
Cleared Nov 14, 1985
DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA
K852284 · LLZ
Radiology · 169d
Cleared Apr 28, 1983
DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE
K828562
Radiology · 163d
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