GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

The GEM Flex Coil 16-L, 16-M, and 16-S arrays are receive-only phased array coils designed for use with GE Healthcare 3.0T MRI systems. They are general-purpose coils used to produce diagnostic images of the head, torso, hip, spine, shoulder, knee, foot, ankle, elbow, and wrist for interpretation by trained physicians.

The proposed devices have identical technological characteristics to the predicate: 16-channel phased array receive-only coils tuned to hydrogen frequency (~64MHz) at 3.0T field strength, with 0.5dB preamplifier noise, active and passive decoupling methods, and compatible with GEHC 3.0T MRI systems using P-Port connectors.

IEC 60601-1:2005, IEC 60601-1-2:2014, ISO 10993-5:2009, ISO 10993-10:2010, NEMA MS-1-2008 (SNR determination), NEMA MS 3-2008 (image uniformity), and IEC 60601-2-33:2010 (MR equipment safety). Bench testing demonstrated image uniformity, signal-to-noise ratio, and coil surface heating met specifications.

The proposed device is substantially equivalent to the predicate GEM Flex Coil 3.0T (K103342) because it has identical anatomical sites, transmit/receive functionality, number of channels, field strength, energy source, compatible systems, coil design, tuning frequency, decoupling method, and biocompatibility compliance—with no new safety or effectiveness issues identified.