DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 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 Mr750 3.0t,optima Mr450w 1.5t.

Pre-market Notification Details

• Device ID: K142085
• 510k Number: K142085
• Device Name: DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 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: Jenny Wong
• Correspondent: Jenny Wong; GE MEDICAL SYSTEMS, LLC 3200 N. 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: 2014-07-31
• Decision Date: 2014-09-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682118187	K142085	000
00840682102445	K142085	000
00840682102469	K142085	000
00840682102704	K142085	000
00840682102728	K142085	000
00840682103787	K142085	000
00840682103817	K142085	000
00840682115872	K142085	000
00840682115971	K142085	000
00840682118088	K142085	000
00840682118118	K142085	000
00840682118132	K142085	000
00840682118170	K142085	000
00840682102438	K142085	000