OEC Elite

Interventional Fluoroscopic X-ray System

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: K171565
• 510k Number: K171565
• Device Name: OEC Elite
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116
• Contact: Rachel Schandel
• Correspondent: Rachel Schandel; GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116
• 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: 2017-05-30
• Decision Date: 2017-08-10
• Summary: summary