16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

The 16ch Flex SPEEDER Medium and Large are receive-only, 16-channel phased array coils designed for magnetic resonance imaging on Canon 1.5T MR systems. They are intended to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

Both the proposed and predicate devices are based on identical technological elements: receive-only phased array RF coils with active PIN diode switching and passive blocking circuitry, housed in polycarbonate with polyurethane-coated nylon fabric covers for impact protection and biocompatibility. No technological differences exist between the proposed and predicate devices.

Signal-to-noise ratio (SNR) and image uniformity were analyzed per NEMA MS-9 (using alternate method 2.5 from MS-6) and NEMA MS-9 (primary method from MS-6). Electrical safety and electromagnetic compatibility testing followed IEC standards. Surface heating was tested per AAMI/ANSI EN60601-1.

The proposed devices have identical technological design, materials, and construction to the predicate device. The indications for use differ only in scope—the proposed devices cover general human anatomy while the predicate specified specific anatomies—but both are used with Canon 1.5T systems to produce diagnostic images. Testing demonstrates equivalent or better performance: SNR and uniformity meet acceptance criteria, surface heating remains below 41°C, clinical images from multiple anatomical regions show diagnostic quality, and no adverse events were observed.