MAGiC

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 Magic.

Pre-market Notification Details

• Device ID: K161397
• 510k Number: K161397
• Device Name: MAGiC
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: GE Medical Systems, LLC 3200 Grandview Blvd Waukesha, WI 53188
• Contact: Mary A. Mayka
• Correspondent: Mary A. Mayka; GE Medical Systems, LLC 3200 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: 2016-05-19
• Decision Date: 2016-08-31
• Summary: summary