The following data is part of a premarket notification filed by Digirad Corp. with the FDA for Cardius 1, 2 And 3 Xpo And 2020tc Spect Imaging Systems.
| Device ID | K070542 |
| 510k Number | K070542 |
| Device Name: | CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-26 |
| Decision Date | 2007-03-23 |
| Summary: | summary |