The following data is part of a premarket notification filed by Viasonix Ltd. with the FDA for Dolphin/iq, Dolphin/4d And Dolphin/max With Dolphin/xf Robot Accessory.
| Device ID | K202742 |
| 510k Number | K202742 |
| Device Name: | Dolphin/IQ, Dolphin/4D And Dolphin/MAX With Dolphin/XF Robot Accessory |
| 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 Raanana, IL 4366105 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | OQQ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-18 |
| Decision Date | 2021-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016880229 | K202742 | 000 |