The following data is part of a premarket notification filed by Viasonix Ltd. with the FDA for Dolphin/iq, Dolphin/4d And Dolphin/max.
| Device ID | K191023 |
| 510k Number | K191023 |
| Device Name: | Dolphin/IQ, Dolphin/4D And Dolphin/MAX |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Viasonix Ltd. 10 Hamelacha Street Raanana, IL 4366105 |
| Contact | Shlomi Deler |
| Correspondent | Shlomi Deler Viasonix Ltd. 10 Hamelacha Street Raanana, IL 4366105 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-17 |
| Decision Date | 2019-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016880328 | K191023 | 000 |
| 07290016880311 | K191023 | 000 |
| 07290016880304 | K191023 | 000 |
| 07290016880212 | K191023 | 000 |