The following data is part of a premarket notification filed by Spectrum Dynamics Ltd. with the FDA for D-spect Processing And Reviewing Workstation.
| Device ID | K160120 |
| 510k Number | K160120 |
| Device Name: | D-SPECT Processing And Reviewing Workstation |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SPECTRUM DYNAMICS LTD. 22 BAREKET STREET Caesarea, IL 30889 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy QSITE 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290108670080 | K160120 | 000 |