The following data is part of a premarket notification filed by Spectrum Dynamics Ltd. with the FDA for D-spect Cardiac Scanner System.
| Device ID | K062450 |
| 510k Number | K062450 |
| Device Name: | D-SPECT CARDIAC SCANNER SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SPECTRUM DYNAMICS LTD. 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein SPECTRUM DYNAMICS LTD. 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-22 |
| Decision Date | 2006-10-20 |
| Summary: | summary |