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FDA 510(k)

维特拉视

K号: K163232 · 2017-07-21

决定日期2017-07-21
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Vitrea View is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K163232. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vitrea View?

Vitrea View is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Vital Images, Inc.. The 510(k) number is K163232.

When did Vitrea View receive FDA 510(k) clearance?

Vitrea View received FDA 510(k) clearance on 2017-07-21, under 510(k) number K163232.

Who is the listed applicant for Vitrea View?

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

What is the FDA product code for Vitrea View?

The FDA product code for Vitrea View is LLZ.

相关临床试验

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列明Vital Images, Inc.为申报人的其他记录

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相关器械(代码:LLZ)

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官方来源

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