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FDA 510(k)

Dolphin/IQ, Dolphin/4D and Dolphin/MAX

K-Number: K191023 · 2019-05-16

ApplicantViasonix , Ltd.
Decision Date2019-05-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dolphin/IQ, Dolphin/4D and Dolphin/MAX is a medical device manufactured by Viasonix , Ltd.. It received FDA 510(k) clearance on 2019-05-16 under approval number K191023. 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, Dolphin/4D and Dolphin/MAX?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX is a medical device that received FDA 510(k) clearance on 2019-05-16. It is manufactured by Viasonix , Ltd.. The 510(k) number is K191023.

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

Dolphin/IQ, Dolphin/4D and Dolphin/MAX received FDA 510(k) clearance on 2019-05-16, under approval number K191023.

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

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

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

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

Other Devices by Viasonix , Ltd.

K170859Dolphin/IQ and Dolphin/4D K192607LiteWalk 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

View on FDA Database →

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

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