GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only

The GEM Flex Coil 16-L/M/S Array is a receive-only phased array coil designed for use with GEHC 1.5T MRI systems to produce diagnostic images of the head, torso, hip, spine, shoulder, knee, foot, ankle, elbow, and wrist. The device comprises three coils of different sizes (large, medium, small) that are tuned to receive radiofrequency signals corresponding to proton precession in a 1.5 Tesla magnetic field, governed by the Larmor equation.

The device has identical technological characteristics to the predicate device: 16-channel receive-only phased array design, 1.5T field strength, 0.5dB preamplifier noise, hydrogen tuning at ~64MHz, active and passive decoupling, surface-contacting patient interface, and compatibility with GEHC 1.5T MRI systems. Both use the same energy source (Scanner/DC 10V) and biocompatibility standards (ISO 10993-5 and ISO 10993-10).

Verification testing was performed per IEC 60601-1:2005 (medical electrical equipment safety), IEC 60601-1-2:2014 (electromagnetic compatibility), ISO 10993-5:2009 and ISO 10993-10:2010 (biocompatibility), NEMA MS-1-2008 (signal-to-noise ratio determination), NEMA MS 3-2008 (image uniformity), and IEC 60601-2-33:2010 (magnetic resonance equipment safety). Bench testing confirmed image uniformity, SNR, and coil surface heating met specified requirements.

The proposed device is substantially equivalent to the predicate device (GEM Flex Coil, 1.5T, K113474) because it has the same design, intended use, technological characteristics, and performance parameters. Both are receive-only phased array coils with identical channel count, field strength, tuning, decoupling methods, and biocompatibility compliance, designed for diagnostic imaging with GEHC 1.5T MRI systems and demonstrating no new safety or effectiveness concerns.