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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 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.

Frequently Asked Questions

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.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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