SIGNA Prime Elite

The SIGNA Prime Elite is a 1.5T whole-body magnetic resonance diagnostic scanner designed to produce high-resolution images of body structures and functions. It is indicated for diagnostic imaging of the head, neck, spine, breast, heart, abdomen, pelvis, joints, and other anatomical regions, with optional contrast agents. Images are interpreted by trained physicians to assist in diagnosis.

The SIGNA Prime Elite uses a 1.5T superconducting magnet with 60 cm bore, water-cooled gradient coil with active shielding, integrated RF body coil with local transmit/receive capability, and Digitize-Per-Pin (DPP) receive architecture. These components are equivalent to the predicate SIGNA Victor. Software features are equivalent to the SIGNA Champion. RF coils used are identical to those of the predicate device.

ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 10993-1, NEMA MS standards for MRI, and NEMA PS3 standard for DICOM.

The SIGNA Prime Elite employs the same fundamental MR technology and operating principles as the predicate SIGNA Victor, with equivalent magnet, gradient, RF transmit, RF receive, and coil subsystems. Both devices underwent identical risk management testing against the same voluntary standards and achieved successful biocompatibility track records. Sample clinical images demonstrate the SIGNA Prime Elite provides diagnostic image quality substantially equivalent to the predicate, and indications for use are unchanged. Therefore, the device raises no different safety or effectiveness questions.