Company ยท US
Digirad Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2013. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2013 | K123408 | ERGO IMAGING SYSTEM Digirad Corp. | IYX |
| Apr 23, 2010 | K100838 | ERGO IMAGING SYSTEM Digirad Corp. | IYX |
| Mar 9, 2009 | K083649 | CARDIUS 3 X-ACT Digirad Corp. | KPS |
| Dec 17, 2008 | K082904 | STASYS MOTION CORRECTION SOFTWARE Digirad Corp. | KPS |
| Sep 12, 2008 | K082368 | CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM Digirad Corp. | KPS |
| Mar 23, 2007 | K070542 | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS Digirad Corp. | KPS |
| Oct 4, 2005 | K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM Digirad Corp. | KPS |
| Jul 13, 2005 | K051549 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM Digirad Corp. | KPS |
| Feb 5, 2003 | K030085 | CARDIUS-1 AND CARDIS-2 Digirad Corp. | KPS |
| Nov 22, 2002 | K023110 | CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 Digirad Corp. | KPS |
| Jun 15, 2001 | K011572 | QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) Digirad Corp. | KPS |
| Nov 4, 1998 | K982855 | DIGIRAD 2020TC SPECT IMAGING SYSTEM Digirad Corp. | KPS |
| May 28, 1997 | K961104 | NOTEBOOK IMAGER Digirad Corp. | IYX |
| Mar 10, 1986 | K854407 | DIGIRAD REUSABLE IMAGE MEDIA Digirad Corp. | LQA |
| Nov 14, 1985 | K852284 | DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA Digirad Corp. | LLZ |
| Apr 28, 1983 | K828562 | DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE Digirad Corp. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||