The following data is part of a premarket notification filed by Digirad Corp. with the FDA for Cardius-1 And Cardis-2.
| Device ID | K030085 |
| 510k Number | K030085 |
| Device Name: | CARDIUS-1 AND CARDIS-2 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DIGIRAD CORP. 9350 TRADE PLACE San Diego, CA 92126 -6334 |
| Contact | Corey Stewart |
| Correspondent | Corey Stewart DIGIRAD CORP. 9350 TRADE PLACE San Diego, CA 92126 -6334 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-09 |
| Decision Date | 2003-02-05 |
| Summary: | summary |