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FDA 510(k)

Advanced 智能體積超聲系統，型號 AiVUS 1000

K 號：K190314 · 2019-10-09

申請人Mednovel Technology, Ltd.
決定日期2019-10-09
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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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官方來源

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