OEC One

Interventional Fluoroscopic X-ray System

GE HUALUN MEDICAL SYSTEMS CO., LTD.

The following data is part of a premarket notification filed by Ge Hualun Medical Systems Co., Ltd. with the FDA for Oec One.

Pre-market Notification Details

• Device ID: K172700
• 510k Number: K172700
• Device Name: OEC One
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: GE HUALUN MEDICAL SYSTEMS CO., LTD. No1 YongChang North Road Beijing Economic Technological Development Zone Beijing, CN 100176
• Contact: Lifeng Wang
• Correspondent: Lifeng Wang; GE HUALUN MEDICAL SYSTEMS CO., LTD. No 1 Yong Chang North Road Beijing Economic Technological Development Zone Beijing, CN 100176
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-07
• Decision Date: 2017-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682125604	K172700	000