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FDA 510(k)

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory

K-Number: K202742 · 2021-01-25

ApplicantViasonix , Ltd.
Decision Date2021-01-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is a medical device manufactured by Viasonix , Ltd.. It received FDA 510(k) clearance on 2021-01-25 under approval number K202742. 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 with Dolphin/XF robot accessory?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is a medical device that received FDA 510(k) clearance on 2021-01-25. It is manufactured by Viasonix , Ltd.. The 510(k) number is K202742.

When was Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory approved by the FDA?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory received FDA 510(k) clearance on 2021-01-25, under approval number K202742.

What company makes Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory?

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory is manufactured by Viasonix , Ltd..

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

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

Other Devices by Viasonix , Ltd.

K170859Dolphin/IQ and Dolphin/4D K192607LiteWalk K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAX K242662Falcon/Xpress (Falcon/Xpress)

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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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