Smart Fit TorsoCardiac 1.5T

The Smart Fit TorsoCardiac 1.5T is a 16-channel phased array receive-only MRI coil designed for high-resolution diagnostic imaging of the torso (chest, abdomen, pelvis), cardiac, long bones, and neck when used with a Philips 1.5T MR system. Images produced by the coil are interpreted by a trained physician for diagnostic purposes.

The subject device has the same fundamental operating principle as the predicate—receiving magnetic resonance signals from hydrogen nuclei while blocking applied RF fields. Key differences include slightly increased thickness and weight due to redesigned coil PCBA layout and a new insulation foam pad, additional positioning marks on the front, and different internal PCBA layout and external cable to enhance thermal performance and image quality.

Compliance demonstrated with IEC 60601-2-33, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, ISO 14971, ISO 15223-1, MS-1-2008 (SNR), MS-3-2008 (image uniformity), MS-9-2008 (phased array coils), MS-14-2019 (RF coil heating), and IEC 62464-1 (essential image quality).

The subject device is substantially equivalent to predicate K232021 because both devices share the same intended use, design principles, and fundamental technology for producing diagnostic MR images. Non-clinical verification and validation tests show acceptance criteria are met, all risks are mitigated, clinical images reviewed by a board-certified radiologist show adequate diagnostic quality, and the modified indications for use (adding long bones, removing head, revising heart to cardiac) do not raise new safety or effectiveness concerns.