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FDA 510(k)

AVIEW

K-Number: K243689 · 2025-03-19

ApplicantCoreline Soft Co., Ltd.
Decision Date2025-03-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVIEW is a medical device manufactured by Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2025-03-19 under approval number K243689. 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?

AVIEW is a medical device that received FDA 510(k) clearance on 2025-03-19. It is manufactured by Coreline Soft Co., Ltd.. The 510(k) number is K243689.

When was AVIEW approved by the FDA?

AVIEW received FDA 510(k) clearance on 2025-03-19, under approval number K243689.

What company makes AVIEW?

AVIEW is manufactured by Coreline Soft Co., Ltd..

What is the FDA product code for AVIEW?

The FDA product code for AVIEW is QIH.

Other Devices by Coreline Soft Co., Ltd.

K171199AVIEW K192040AVIEW Modeler K201710A View LCS K200714AVIEW K193220AVIEW LCS K214036AVIEW

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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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