Aview

FDA 510(k) K200714 · Coreline Soft Co., Ltd.

Substantially Equivalent

510(k) numberK200714

Submission

Device name
Aview
Applicant
Coreline Soft Co., Ltd.
Seoul, KR
Received
March 18, 2020
Decision date
August 26, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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More from Avara Software

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K214036AviewQIH · Traditional 12/23/2022SE
K220408Aview RT AcsQKB · Traditional 11/10/2022SE
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Questions and answers

When was Aview cleared by the FDA?

Aview (K200714) received a 510(k) decision of Substantially Equivalent on August 26, 2020, 161 days after the submission was received.

What is the product code of K200714?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.