SIGNA™ Sprint

The SIGNA™ Sprint is a whole-body 1.5T magnetic resonance scanner designed to produce diagnostic images of the entire body, including the head, neck, spine, breast, heart, abdomen, pelvis, joints, and musculoskeletal regions. It generates axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and dynamic images that reflect the spatial distribution of nuclei exhibiting magnetic resonance, assisting trained physicians in diagnosis.

The SIGNA™ Sprint is a 1.5T superconducting magnet system (versus 3.0T in the predicate SIGNA™ Premier), featuring a gradient coil with modified DC resistance and AC impedance for reduced cooling, an embedded body coil redesigned to reduce thermal effects, a newly designed 1.5T AIR Posterior Array, a detachable patient table, and the same Digitize-Per-Pin RF receive architecture operating at 1.5T RF frequency. The fundamental technology and operating principles remain equivalent to the predicate device.

Testing included ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 10993-1, and NEMA standards MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, MS 9, MS 14, and PS 3.1–3.20. Quality assurance included risk analysis, design reviews, module and system verification testing, performance testing, and simulated use validation.

The SIGNA™ Sprint has identical indications for use and employs the same fundamental scientific technology and operating principles as the predicate SIGNA™ Premier, differing only in magnet field strength (1.5T versus 3.0T) and component modifications that do not raise new safety or effectiveness questions. Non-clinical testing to the same voluntary standards and clinical image quality samples demonstrate that the device performs as intended with image quality substantially equivalent to the predicate, establishing substantial equivalence despite the field strength difference.