Medical Device Manufacturer · US , Palo Alto , CA

Digirad Corp.

16 submissions · 16 cleared · Since 1983
16
Total
16
Cleared
0
Denied

Digirad Corp. — FDA 510(k) Submissions

Digirad Corp. has submitted 16 FDA 510(k) premarket notifications since 1983, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Tomography, Computed, Emission, Camera, Scintillation (gamma), System, Image Processing, Radiological, Media, Reusable Image . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
ERGO IMAGING SYSTEM
K123408 · IYX Camera, Scintillation... · Radiology
Jan 2013 71d
ERGO IMAGING SYSTEM
K100838 · IYX Camera, Scintillation... · Radiology
Apr 2010 30d
CARDIUS 3 X-ACT
K083649 · KPS System, Tomography,... · Radiology
Mar 2009 90d
STASYS MOTION CORRECTION SOFTWARE
K082904 · KPS System, Tomography,... · Radiology
Dec 2008 78d
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM
K082368 · KPS System, Tomography,... · Radiology
Sep 2008 25d
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
K070542 · KPS System, Tomography,... · Radiology
Mar 2007 25d
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K052430 · KPS System, Tomography,... · Radiology
Oct 2005 28d
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K051549 · KPS System, Tomography,... · Radiology
Jul 2005 30d
CARDIUS-1 AND CARDIS-2
K030085 · KPS System, Tomography,... · Radiology
Feb 2003 27d
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
K023110 · KPS System, Tomography,... · Radiology
Nov 2002 64d
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · KPS System, Tomography,... · Radiology
Jun 2001 25d
DIGIRAD 2020TC SPECT IMAGING SYSTEM
K982855 · KPS System, Tomography,... · Radiology
Nov 1998 90d
NOTEBOOK IMAGER
K961104 · IYX Camera, Scintillation... · Radiology
May 1997 434d
DIGIRAD REUSABLE IMAGE MEDIA
K854407 · LQA Media, Reusable Image · Radiology
Mar 1986 129d
DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA
K852284 · LLZ System, Image Processing,... · Radiology
Nov 1985 169d
DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE
K828562 · Radiology
Apr 1983 163d
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