Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

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 Discovery Mr750 3.0t, Discovery Mr450 1.5t, Discovery Mr750w 3.0t, Optima Mr450w 1.5t.

Pre-market Notification Details

• Device ID: K160618
• 510k Number: K160618
• Device Name: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188
• Contact: Jason Ma
• Correspondent: Jason Ma; GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-03
• Decision Date: 2016-06-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682123457	K160618	000
00840682123440	K160618	000
00840682123129	K160618	000
00840682122702	K160618	000