OrthoVision

System, Image Processing, Radiological

Ewoo Soft Co., Ltd.

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

Pre-market Notification Details

• Device ID: K173094
• 510k Number: K173094
• Device Name: OrthoVision
• Classification: System, Image Processing, Radiological
• Applicant: Ewoo Soft Co., Ltd. 801-ho, Vatechnetworks Bldg. 13, Samsung 1-ro 2-gil Hwaseong-si, KR 18449
• Contact: Young Seok Kim
• 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-29
• Decision Date: 2017-10-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800019700081	K173094	000