Submission Details
| 510(k) Number | K170859 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2017 |
| Decision Date | November 14, 2017 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
K170859 - Dolphin/IQ and Dolphin/4D
(FDA 510(k) Clearance)
Nov 2017
Decision
237d
Days
Class 2
Risk
K170859 is an FDA 510(k) clearance for the Dolphin/IQ and Dolphin/4D. 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 November 14, 2017, 237 days after receiving the submission on March 22, 2017.
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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