S-scan Open (100001800)

The S-scan Open is a magnetic resonance imaging (MRI) system that produces cross-sectional images of internal body structures by measuring proton distribution and magnetic resonance properties. It is designed to scan targeted body areas including limbs, joints, spine, and head to collect, display, and analyze MR images for diagnostic purposes.

The S-scan Open maintains unchanged core technical specifications including magnet characteristics and field strength from its predicate device (S-scan, K161973). Key differences include new software version MRI EVOlution 25 with features like HyperClarity AI algorithm, 3D viewer, prone patient positioning, updated Windows 10 operating system, new graphical user interface, and three new receiving coils (XL flex L-Spine coil 10, Flex coil 11, Knee coil 21). A patient alert system was also added.

The device was evaluated for compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 10993-1, ISO 14971, and NEMA MS-14. Verification and validation documents were provided demonstrating acceptable diagnostic image quality per FDA guidance.

S-scan Open is substantially equivalent because it maintains identical indications for use, the same fundamental MRI technology, and unchanged core technical specifications as the predicate S-scan (K161973). Although software and hardware features were upgraded, all modifications consist of features previously cleared on other Esaote MRI systems or incremental enhancements. Verification and validation testing confirmed all acceptance criteria were met and no new safety or effectiveness questions were raised.