FDA 510(k)

AVIEW CAC

K-Number: K233211 · 2024-03-29

Decision Date2024-03-29

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AVIEW CAC is the device name listed in this FDA 510(k) record. The listed applicant is Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2024-03-29 under 510(k) number K233211. 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 AVIEW CAC?

AVIEW CAC is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K233211.

When did AVIEW CAC receive FDA 510(k) clearance?

AVIEW CAC received FDA 510(k) clearance on 2024-03-29, under 510(k) number K233211.

Who is the listed applicant for AVIEW CAC?

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

What is the FDA product code for AVIEW CAC?

The FDA product code for AVIEW CAC is QIH.

Other records listing Coreline Soft Co., Ltd. as applicant

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.

K251203AVIEW Lung Nodule CAD K243689AVIEW K243696AVIEW CAC K221592AVIEW Lung Nodule CAD K214036AVIEW K220408AVIEW RT ACS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.