FDA 510(k)

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

K-Number: K191023 · 2019-05-16

Decision Date2019-05-16

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Dolphin/IQ, Dolphin/4D and Dolphin/MAX is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) 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. The listed applicant is Viasonix , Ltd.. The 510(k) number is K191023.

When did Dolphin/IQ, Dolphin/4D and Dolphin/MAX receive FDA 510(k) clearance?

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

Who is the listed applicant for Dolphin/IQ, Dolphin/4D and Dolphin/MAX?

The FDA 510(k) record lists Viasonix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Viasonix , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242662Falcon/Xpress (Falcon/Xpress)K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory K192607LiteWalk K170859Dolphin/IQ and Dolphin/4D

Related Devices (Code: IYN)

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.