Digirad Corp.
San Diego, CA, US
Digirad Corp. appears in FDA device records in San Diego, CA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Digirad Corp. between 1983 and 2013. The busiest year on record is 2005, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123408 | ERGO IMAGING SYSTEM | IYX | Substantially Equivalent | |
| K100838 | ERGO IMAGING SYSTEM | IYX | Substantially Equivalent | |
| K083649 | CARDIUS 3 X-ACT | KPS | Substantially Equivalent | |
| K082904 | STASYS MOTION CORRECTION SOFTWARE | KPS | Substantially Equivalent | |
| K082368 | CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K070542 | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS | KPS | Substantially Equivalent | |
| K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K051549 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K030085 | CARDIUS-1 AND CARDIS-2 | KPS | Substantially Equivalent | |
| K023110 | CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 | KPS | Substantially Equivalent | |
| K011572 | QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) | KPS | Substantially Equivalent | |
| K982855 | DIGIRAD 2020TC SPECT IMAGING SYSTEM | KPS | Substantially Equivalent | |
| K961104 | NOTEBOOK IMAGER | IYX | Substantially Equivalent | |
| K854407 | DIGIRAD REUSABLE IMAGE MEDIA | LQA | Substantially Equivalent | |
| K852284 | DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA | LLZ | Substantially Equivalent | |
| K828562 | DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain