INNOVA 3100

Interventional Fluoroscopic X-ray System

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Innova 3100.

Pre-market Notification Details

• Device ID: K031637
• 510k Number: K031637
• Device Name: INNOVA 3100
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188
• Contact: Larry Kroger
• Correspondent: Larry Kroger; GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-27
• Decision Date: 2003-08-22
• Summary: summary