AVIEW

System, Image Processing, Radiological

Coreline Soft Co., Ltd.

The following data is part of a premarket notification filed by Coreline Soft Co., Ltd. with the FDA for Aview.

Pre-market Notification Details

• Device ID: K171199
• 510k Number: K171199
• Device Name: AVIEW
• Classification: System, Image Processing, Radiological
• Applicant: Coreline Soft Co., Ltd. 4,5F (Yeonnam-dong), 49, World Cup Buk-ro 6-gil, Mapo-gu Seoul, KR 03991
• Contact: Hye Yi Park
• Correspondent: Priscilla Chung; Lk Consulting Group USA, Inc 690 Roosevelt Irvine, CA 92620
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-24
• Decision Date: 2018-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800025300015	K171199	000