The following data is part of a premarket notification filed by Viasonix Ltd. with the FDA for Dolphin/iq And Dolphin/4d.
| Device ID | K170859 |
| 510k Number | K170859 |
| Device Name: | Dolphin/IQ And Dolphin/4D |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Viasonix Ltd. 10 Hamelacha Street Raananna, IL 4366105 |
| Contact | Dan Manor |
| Correspondent | Dan Manor Viasonix Ltd. 10 Hamelacha Street Raananna, IL 4366105 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-22 |
| Decision Date | 2017-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016880106 | K170859 | 000 |
| 07290016880090 | K170859 | 000 |
| 07290016880083 | K170859 | 000 |
| 07290016880069 | K170859 | 000 |
| 07290016880052 | K170859 | 000 |
| 07290016880045 | K170859 | 000 |
| 07290016880038 | K170859 | 000 |