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: K200714
• 510k Number: K200714
• 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 03391
• Contact: Hyeyi Park
• Correspondent: Hyeyi Park; Coreline Soft Co., Ltd 4, 5F (Yeonnam-dong) 49, World Cup Buk-ro-6-gil, Mapo-gu Seoul, KR 03391
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-18
• Decision Date: 2020-08-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800025300077	K200714	000