The following data is part of a premarket notification filed by Spectrum Dynamics Medical Ltd with the FDA for D-spect Scanner, D-spect L Scanner.
| Device ID | K161740 |
| 510k Number | K161740 |
| Device Name: | D-SPECT Scanner, D-SPECT L Scanner |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Spectrum Dynamics Medical Ltd 22 Bareket St Caesarea, IL 3088900 |
| Contact | Igor Naroditsky |
| Correspondent | Igor Naroditsky Spectrum Dynamics Medical Ltd 22 Bareket St Caesarea, IL 3088900 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-24 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290108670073 | K161740 | 000 |
| 07290108670066 | K161740 | 000 |
| 00729018670141 | K161740 | 000 |
| 07290108670134 | K161740 | 000 |
| 00729018670158 | K161740 | 000 |
| 07290108670141 | K161740 | 000 |
| 07290108670158 | K161740 | 000 |