OEC One

Image-intensified Fluoroscopic X-ray System, Mobile

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: K182626
• 510k Number: K182626
• Device Name: OEC One
• Classification: Image-intensified Fluoroscopic X-ray System, Mobile
• Applicant: GE Hualun Medical Systems Co., Ltd. No.1 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 YongChang North Road, Beijing Economic Technological Development Zone Beijing, CN 100176
• Product Code: OXO
• Subsequent Product Code: JAA
• Subsequent Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-24
• Decision Date: 2018-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682145541	K182626	000