Cleared Traditional

AVIEW

K200714 · Coreline Soft Co., Ltd. · Radiology
Aug 2020
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K200714 is an FDA 510(k) clearance for the AVIEW, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Coreline Soft Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on August 26, 2020, 161 days after receiving the submission on March 18, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K200714 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2020
Decision Date August 26, 2020
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050