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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 a medical device manufactured by Mednovel Technology, Ltd.. It received FDA 510(k) clearance on 2019-10-09 under approval 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. It is manufactured by Mednovel Technology, Ltd.. The 510(k) number is K190314.

When was Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 approved by the FDA?

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

What company makes Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000?

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 is manufactured by Mednovel Technology, Ltd..

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

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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