Cleared Traditional

AVIEW Modeler

K192040 · Coreline Soft Co., Ltd. · Radiology

Dec 2019

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K192040 is an FDA 510(k) clearance for the AVIEW Modeler, 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 December 20, 2019, 142 days after receiving the submission on July 31, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K192040 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2019
Decision Date	December 20, 2019
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF