SIGNA™ Sprint Select

The SIGNA™ Sprint Select is a whole-body 1.5T magnetic resonance scanner designed for diagnostic imaging. It produces axial, sagittal, coronal, and oblique images of structures throughout the body including the brain, spine, heart, abdomen, joints, and blood vessels, with optional contrast agents to support clinical diagnosis.

The proposed device offers two magnet options (Demeter and IPM), with the IPM being identical to the predicate and the Demeter electromagnetically equivalent. The gradient subsystem, RF transmit (excluding body coil), detachable RF coils, and gating accessories are identical or equivalent to the predicate SIGNA™ Sprint. The RF receive subsystem includes an updated FPGA, and the software platform features an updated user interface with productivity enhancements, though the base functionality remains equivalent to the predicate.

Testing complied with IEC 60601-1 Edition 3.2, IEC 60601-2-33 Edition 4.0, ANSI/AAMI standards, IEC 62464-1, NEMA MS series standards (MS-1 through MS-8), and ISO 10993-1 biocompatibility testing. Quality assurance measures included risk analysis, design reviews, module and system verification testing, and performance validation.

The SIGNA™ Sprint Select is substantially equivalent because it employs the same fundamental MR technology and operating principles as its predicate device (SIGNA™ Sprint K251399), has identical or equivalent subsystems across magnet, gradient, RF, and coil components, uses the same indications for use, and non-clinical testing demonstrates equivalent safety and performance. Clinical images reviewed by a board-certified radiologist confirmed sufficient diagnostic quality.