SIGNA™ Bolt

The SIGNA™ Bolt is a whole-body 3.0T magnetic resonance imaging system designed to produce high-resolution diagnostic images of body structures including the head, spine, heart, abdomen, joints, and blood vessels. It can generate axial, sagittal, coronal, and oblique images, as well as spectroscopic data and parametric maps to assist physicians in diagnosis.

The SIGNA™ Bolt features a ZRMW gradient coil (versus the predicate's HRMW) that reduces heat generation, an upgraded RF transmit architecture with 36 kW peak power in an in-scan-room configuration, RF receive chains with 162 or 130 channels depending on configuration, and new contactless gating technology for physiological monitoring without physical accessories. Software enhancements include AIRx automated slice prescription extended to spine and prostate imaging, and SIGNA One Camera for AI-assisted patient positioning.

Testing followed ANSI/AAMI/IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, ISO 10993-1, IEC 62464-1, NEMA MS 1/3/4/6/8/9/14, NEMA PS 3.1-3.20, plus FDA guidance on device software and cybersecurity.

The SIGNA™ Bolt is substantially equivalent to the predicate SIGNA™ Premier (K193282) because it uses the same fundamental MRI technology, 3.0T magnet, and indications for use. Design modifications such as the improved gradient coil, RF transmit architecture, contactless gating, and AI-assisted software features do not raise new safety or effectiveness concerns and maintain the same diagnostic imaging capability as the predicate device.