LiverMultiScan (v6.0)

LiverMultiScan v6.0 is a software-as-a-medical-device that processes magnetic resonance (MR) imaging data to assess liver health. It generates three quantitative metrics—iron-corrected T1 (cT1), proton density fat fraction (PDFF), and liver iron concentration (LIC)—that reflect fibroinflammation, steatosis, and iron overload respectively. The output is intended for interpretation by trained healthcare professionals to assist clinical decision-making regarding liver tissue characteristics.

The subject device adds capability to process MR data acquired via NOLLI (non-MOLLI) sequences in addition to the predicate's MOLLI method. The LIC calculation equation was updated to align with reference literature, and the cT1 calculation was refined to account for T1 signal variations due to elevated fat content. All other specifications remain identical: DICOM 3.0 input format, compatibility with GE/Siemens/Philips scanners at 1.5T and 3T field strengths, and the same three quantitative outputs.

ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action) are cited as applicable quality management requirements. The document references FDA guidance on device software from June 14, 2023, but does not cite specific consensus standards (ISO, IEC, ASTM) for the imaging algorithms or performance metrics themselves.

Substantial equivalence is claimed because the subject device uses the same indications for use, anatomy, imaging modality, data format, and scanner compatibility as the predicate LiverMultiScan v5.0. Although the LIC and cT1 calculation methods were refined, performance testing across all major scanner types and field strengths demonstrated that the subject device is at least as safe and effective as the predicate. The differences do not constitute new intended uses and do not raise different safety or effectiveness questions than the predicate.