The following data is part of a premarket notification filed by Spectrum Dynamics Medical Ltd with the FDA for Veriton Ct Whole Body Spect/ct System.
| Device ID | K190457 |
| 510k Number | K190457 |
| Device Name: | VERITON CT Whole Body SPECT/CT System |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Spectrum Dynamics Medical Ltd 22 Bareket St. North Industrial Park. Caesarea, IL 3079837 |
| Contact | Igor Naroditsky |
| Correspondent | Igor Naroditsky Spectrum Dynamics Medical Ltd 22 Bareket St. North Industrial Park. Caesarea, IL 3079837 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290108670127 | K190457 | 000 |