FDA 510(k)

Dolphin/IQ and Dolphin/4D

K-Number: K170859 · 2017-11-14

Decision Date2017-11-14

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Dolphin/IQ and Dolphin/4D is a medical device manufactured by Viasonix , Ltd.. It received FDA 510(k) clearance on 2017-11-14 under approval number K170859. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dolphin/IQ and Dolphin/4D?

Dolphin/IQ and Dolphin/4D is a medical device that received FDA 510(k) clearance on 2017-11-14. It is manufactured by Viasonix , Ltd.. The 510(k) number is K170859.

When was Dolphin/IQ and Dolphin/4D approved by the FDA?

Dolphin/IQ and Dolphin/4D received FDA 510(k) clearance on 2017-11-14, under approval number K170859.

What company makes Dolphin/IQ and Dolphin/4D?

Dolphin/IQ and Dolphin/4D is manufactured by Viasonix , Ltd..

What is the FDA product code for Dolphin/IQ and Dolphin/4D?

The FDA product code for Dolphin/IQ and Dolphin/4D is IYN.

Other Devices by Viasonix , Ltd.

K192607LiteWalk K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAX K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory K242662Falcon/Xpress (Falcon/Xpress)

Related Devices (Code: IYN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.