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FDA 510(k)

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

K-Number: K190314 · 2019-10-09

ApplicantMednovel Technology, Ltd.
Decision Date2019-10-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Mednovel Technology, Ltd.. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K190314. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000?

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Mednovel Technology, Ltd.. The 510(k) number is K190314.

When did Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 receive FDA 510(k) clearance?

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 received FDA 510(k) clearance on 2019-10-09, under 510(k) number K190314.

Who is the listed applicant for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000?

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

What is the FDA product code for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000?

The FDA product code for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 is IYO.

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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.

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