HD 8Ch Wrist Array

The HD 8Ch Wrist Array is a receive-only coil designed for use with GE Healthcare 1.5T MRI systems to produce diagnostic images of the wrists and fingers for interpretation by trained physicians. It is a general-purpose coil that operates at hydrogen resonance frequency (~64 MHz) in a 1.5 Tesla magnetic field.

The device is an 8-channel phased array coil with 0.5 dB preamplifier noise, surface-contacting patient interface, and active plus passive decoupling. It uses Scanner/DC 10V power and is compatible with GEHC 1.5T MRI systems. All technological characteristics—anatomical site, transmit/receive function, channel count, field strength, coil design, tuning, and decoupling method—are identical to the predicate device K223239.

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), NEMA MS 3-2008 (image uniformity), and IEC 60601-2-33:2010+A1:2013+A2:2015 (MR equipment safety).

The HD 8Ch Wrist Array is substantially equivalent to predicate device K223239 (8ch Wrist Coil by the same manufacturer) because it has identical design, energy source, compatible systems, number of channels, field strength, and all other technological characteristics. Bench testing confirmed that image uniformity, signal-to-noise ratio, and coil surface heating meet specified requirements and satisfy all applicable standards, demonstrating no new safety or effectiveness issues.