Cleared Traditional

AVIEW

K171199 · Coreline Soft Co., Ltd. · Radiology
Oct 2018
Decision
555d
Days
Class 2
Risk

About This 510(k) Submission

K171199 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 October 31, 2018, 555 days after receiving the submission on April 24, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K171199 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2017
Decision Date October 31, 2018
Days to Decision 555 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