FDA 510(k)

AVIEW LCS

K-Number: K193220 · 2020-05-05

Decision Date2020-05-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AVIEW LCS 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 2020-05-05 under 510(k) number K193220. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVIEW LCS?

AVIEW LCS is a medical device that received FDA 510(k) clearance on 2020-05-05. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K193220.

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

AVIEW LCS received FDA 510(k) clearance on 2020-05-05, under 510(k) number K193220.

Who is the listed applicant for AVIEW LCS?

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 LCS?

The FDA product code for AVIEW LCS is LLZ.

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 K233211AVIEW CAC K221592AVIEW Lung Nodule CAD K214036AVIEW

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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.