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

Digirad Corp. has 16 FDA 510(k) cleared radiology devices. Based in Palo Alto, US.

Historical record: 16 cleared submissions from 1983 to 2013.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Digirad Corp.
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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