AMX Navigate

System, X-ray, Mobile

GE Medical Systems, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Amx Navigate.

Pre-market Notification Details

• Device ID: K210982
• 510k Number: K210982
• Device Name: AMX Navigate
• Classification: System, X-ray, Mobile
• Applicant: GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188
• Contact: Martha Kamrow
• Correspondent: Martha Kamrow; GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-01
• Decision Date: 2021-04-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195278003348	K210982	000
00195278798374	K210982	000