K191023 is an FDA 510(k) clearance for the Dolphin/IQ, Dolphin/4D and Dolphin/MAX. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Viasonix , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on May 16, 2019, 29 days after receiving the submission on April 17, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K191023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2019 |
| Decision Date | May 16, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN - System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |