The following data is part of a premarket notification filed by Digirad Corp. with the FDA for Quantitative Gated Spect (qgs), Quantitative Perfusion Spect (qps).
| Device ID | K011572 |
| 510k Number | K011572 |
| Device Name: | QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-21 |
| Decision Date | 2001-06-15 |
| Summary: | summary |