Data / Medical devices / United States / Digirad Diagnostic Imaging, LLC
Digirad Diagnostic Imaging, LLC: FDA-registered device maker in Poway, CA, United States, 3 510(k) clearances
Digirad Diagnostic Imaging, LLC is registered with the FDA (registration 2031050) in Poway, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 15, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031050
- FEI number
- 3001236767
- Address
- 13100 Gregg St Ste A, Poway, CA, United States, 92064
- Owner or operator
- Digirad Diagnostic Imaging (9031213)
- Roles
- Manufacturer
- First device listed
- May 2, 2006
- Registered through
- 2026
- Brand names listed
- 2020tc Imaging System, Cardius® 1, Cardius® 1M, Cardius® 2, Cardius® 2M, Cardius® 2MXPO, Cardius® 2XPO, Cardius® 3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 15, 2013 | K123408 | ERGO IMAGING SYSTEM | IYX | Substantially Equivalent | Digirad Corp. | accessdata.fda.gov |
| October 4, 2005 | K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM | KPS | Substantially Equivalent | Digirad Corp. | accessdata.fda.gov |
| May 28, 1997 | K961104 | NOTEBOOK IMAGER | IYX | Substantially Equivalent | Digirad Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 15, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.