iCAS-LV
K号: K231690 · 2024-03-01
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器械摘要
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.
常见问题
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.
相关器械(代码:QIH)
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官方来源
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