Submission Details
| 510(k) Number | K202742 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 18, 2020 |
| Decision Date | January 25, 2021 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
K202742 - Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
(FDA 510(k) Clearance)
Jan 2021
Decision
129d
Days
Class 2
Risk
K202742 is an FDA 510(k) clearance for the Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory. 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 January 25, 2021, 129 days after receiving the submission on September 18, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
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