FDA 510(k)

iCAS-LV

K 號：K231690 · 2024-03-01

決定日期2024-03-01

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

iCAS-LV is the device name listed in this FDA 510(k) record. The listed applicant is Highrad , Ltd.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K231690. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iCAS-LV?

iCAS-LV is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Highrad , Ltd.. The 510(k) number is K231690.

When did iCAS-LV receive FDA 510(k) clearance?

iCAS-LV received FDA 510(k) clearance on 2024-03-01, under 510(k) number K231690.

Who is the listed applicant for iCAS-LV?

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

What is the FDA product code for iCAS-LV?

The FDA product code for iCAS-LV is QIH.

相關器械（代碼：QIH）

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官方來源

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