HyperBand

System, Nuclear Magnetic Resonance Imaging

GE Medical Systems, LLC

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

Pre-market Notification Details

• Device ID: K162403
• 510k Number: K162403
• Device Name: HyperBand
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: GE Medical Systems, LLC 3200 North Grandview Blvd Waukesha, WI 53188
• Contact: Jason Ma
• Correspondent: Glen Sabin; GE Medical Systems, LLC 3200 North Grandview Blvd Waukesha, WI 53188
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-29
• Decision Date: 2016-11-18
• Summary: summary