APERTO Lucent MRI System

The APERTO Lucent MRI System is a 0.4 Tesla magnetic resonance imaging device that produces cross-sectional images of the head, body, spine, and extremities without ionizing radiation. It provides physicians with physiological and clinical information useful for diagnosis, supporting T1/T2 weighted imaging, diffusion weighted imaging, MR angiography, and image processing.

The subject device is identical to the predicate (K233629) in hardware, magnet strength (0.4T permanent magnet), gradient system, RF system, operating system, CPU platform, and software functionality. The only differences are three newly added receiver coils: QD Flexible Body coil N (M), Joint coil(S), and Open Body coil, which do not constitute new intended uses or significant technological changes.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304; NEMA MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, and MS 14 standards covering signal-to-noise ratio, geometric distortion, image uniformity, acoustic noise, slice thickness, specific absorption rate, and RF coil heating.

The APERTO Lucent is substantially equivalent to its predicate device because hardware, software functionality, and control systems are identical, with no differences in safety or effectiveness. The three added coils do not introduce new intended uses or raise different safety questions; they maintain the same technological characteristics and undergo the same regulatory controls as the predicate, with clinical imaging validation confirming acceptable image quality.