Hepatica v1 (Hepatica v1.0.0)
K203280Perspectum Ltd. · cleared 2021-01-12 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health.”
source quote (p.3)
“Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health. Hepatica v1 supports semi-automatic liver segmentation of T1-weighted volumetric data. Liver segmentation in Hepatica v1 requires the placement of anatomical landmarks to define the outer contours of the liver and can be adjusted by the operator, where necessary.”
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: Accuracy; Repeatability; Reproducibility; Inter and intra operator variability
standards: IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485
Reported performance (3 observations)
source quote (p.12)
“Table 2: Performance testing results for Hepatica v1 accuracy when compared to the gold standard (radiologists)”
source quote (p.12)
“Table 2: Performance testing results for Hepatica v1 accuracy when compared to the gold standard (radiologists)”
source quote (p.12)
“Table 2: Performance testing results for Hepatica v1 accuracy when compared to the gold standard (radiologists)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).