The following data is part of a premarket notification filed by Digirad Corp. with the FDA for Cardius 3 X-act.
| Device ID | K083649 |
| 510k Number | K083649 |
| Device Name: | CARDIUS 3 X-ACT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DIGIRAD CORP. 13950 STOWE DRIVE Poway, CA 92064 -8803 |
| Contact | Joel Tuckey |
| Correspondent | Joel Tuckey DIGIRAD CORP. 13950 STOWE DRIVE Poway, CA 92064 -8803 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-09 |
| Decision Date | 2009-03-09 |
| Summary: | summary |