Magnifico Open (100009900)

The Magnifico Open is a magnetic resonance imaging (MRI) system designed to produce cross-sectional images of internal body structures by detecting hydrogen nuclei properties. It is a general-purpose MRI device intended for scanning targeted areas including limbs, spine, pelvis, temporomandibular joint, head, and upper abdomen to collect, display, and analyze MR images for diagnostic purposes.

The updated Magnifico maintains identical core magnet components and magnetic field strength to the predicate device. New features include software version MRI EVOiution 25 with HyperClarity (AI-based image enhancement), an abdominal imaging package with breathing management and respiratory gating system, 3D FSE sequences, ROTAR sequences, knee movement support, modified maximum gradient intensity, and new receiving coils (DPA Shoulder Coil, Flex Coil, 4-channel Foot/Ankle coil).

Testing confirms compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-33, IEC 62304, IEC 62366-1, ISO 10993-1, ISO 14971, NEMA MS-1, NEMA MS-3, and NEMA MS-14. The device was evaluated for biocompatibility, thermal, electrical, electromagnetic, and mechanical safety.

Magnifico is substantially equivalent to predicate K241133 because core components remain unchanged and identical, fundamental scientific technology and operating principles are the same, and all performance testing confirms the updated device meets applicable safety and performance standards with no new questions of safety or effectiveness raised compared to the predicate.