The following data is part of a premarket notification filed by Spectrum Dynamics Ltd. with the FDA for Modification To D-spect Cardiac Scanner System.
| Device ID | K072468 |
| 510k Number | K072468 |
| Device Name: | MODIFICATION TO 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-04 |
| Decision Date | 2007-10-01 |
| Summary: | summary |