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FDA 510(k)

iCAS-LV

K-Number: K231690 · 2024-03-01

ApplicantHighrad , Ltd.
Decision Date2024-03-01
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the iCAS-LV?

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

When was iCAS-LV approved by the FDA?

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

What company makes iCAS-LV?

iCAS-LV is manufactured by Highrad , Ltd..

What is the FDA product code for iCAS-LV?

The FDA product code for iCAS-LV is QIH.

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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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