PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL

System, Nuclear Magnetic Resonance Imaging

MEDICAL ADVANCES, INC.

The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Phased Array Shoulder Coil, Quadrature Shoulder Coil.

Pre-market Notification Details

• Device ID: K945778
• 510k Number: K945778
• Device Name: PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226
• Contact: Thomas E Tynes
• Correspondent: Thomas E Tynes; MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-25
• Decision Date: 1995-03-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838066366	K945778	000
00884838065710	K945778	000