The following data is part of a premarket notification filed by Digirad Corp. with the FDA for Digirad 2020tc Spect Imaging System.
| Device ID | K982855 |
| 510k Number | K982855 |
| Device Name: | DIGIRAD 2020TC SPECT IMAGING SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DIGIRAD CORP. 7408 TRADE ST. San Diego, CA 92121 -2410 |
| Contact | R. Scott Huennekens |
| Correspondent | R. Scott Huennekens DIGIRAD CORP. 7408 TRADE ST. San Diego, CA 92121 -2410 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1998-11-04 |
| Summary: | summary |