OEC Elite

Image-intensified Fluoroscopic X-ray System, Mobile

GE OEC Medical Systems, Inc.

The following data is part of a premarket notification filed by Ge Oec Medical Systems, Inc. with the FDA for Oec Elite.

Pre-market Notification Details

• Device ID: K192819
• 510k Number: K192819
• Device Name: OEC Elite
• Classification: Image-intensified Fluoroscopic X-ray System, Mobile
• Applicant: GE OEC Medical Systems, Inc. 384 N Wright Brothers Drive Salt Lake City, UT 84116
• Contact: Kenny M Bello
• Correspondent: Kenny M Bello; GE OEC Medical Systems, Inc. 384 N Wright Brothers Drive Salt Lake City, UT 84116
• Product Code: OXO
• Subsequent Product Code: JAA
• Subsequent Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-01
• Decision Date: 2019-11-08