Cleared Traditional

A View LCS

K201710 · Coreline Soft Co., Ltd. · Radiology
Oct 2020
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K201710 is an FDA 510(k) clearance for the A View LCS, 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 October 16, 2020, 115 days after receiving the submission on June 23, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K201710 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2020
Decision Date October 16, 2020
Days to Decision 115 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