GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL

Coil, Magnetic Resonance, Specialty

GE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Signa Excite 1.5t 6 Channel Phased Array Flex Coil, Ge Signa Excite 3.0t 6 Channel Phased Array Flex Coil.

Pre-market Notification Details

• Device ID: K042844
• 510k Number: K042844
• Device Name: GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
• Classification: Coil, Magnetic Resonance, Specialty
• Applicant: GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201
• Contact: Larry Kroger
• Correspondent: Larry Kroger; GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201
• Product Code: MOS
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-15
• Decision Date: 2004-11-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682119894	K042844	000
00840682119887	K042844	000
00840682119870	K042844	000
00840682119863	K042844	000