0.55T 12Ch Breast Coil

The NeoCoil 0.55T 12Ch Breast Coil is a magnetic resonance imaging (MRI) RF receive-only coil designed for use with compatible 0.55T MRI systems. It is intended for trained medical professionals to acquire diagnostic and interventional planning images of the breast, axilla, and chest wall. The coil consists of a phased array design with 12 channels organized into lateral, biopsy, and medial arrays, along with patient support structures and biopsy accessories.

The 0.55T 12Ch device is similar in design, materials, and energy source to its predicate (1.5T and 3T 16Ch Breast Coil, K222407). Key differences include: usability features (optional biopsy risers, LED illumination, color-coded labels), electrical/EMC characteristics (MRI-specific cabling, interface circuitry, RF tuning, and 12 channels instead of 16), and labeling updates (USB for electronic instructions). The fundamental technological elements—receive-only phased array design, fuses, preamplification, decoupling methodology, and mechanical contours for breast anatomy—remain the same.

Biocompatibility assessment, IEC 60601-1 (basic electrical safety), IEC 60601-2-33 (particular requirements for MR equipment), IEC 60601-1-2 (collateral electrical safety), NEMA MS 6-2008 (single-channel non-volume RF coils for MRI systems). Testing also included bench and MRI scanner-based performance evaluations for B0/B1 field distortion, surface temperature, blocking network analysis, and signal-to-noise ratio/image uniformity.

Substantial equivalence is established because the 0.55T 12Ch Breast Coil demonstrates the same intended use, technological basis, and safety/effectiveness profile as the predicate device. All performance testing—including electrical safety, biocompatibility, field distortion, and image quality metrics—met predefined standards. The differences in channel count, field strength, and usability features do not adversely affect safety or effectiveness, and no additional clinical testing was required due to demonstrated technological and functional equivalence. No adverse events have been reported for the predicate device.