HepaFatSmart (V2.0.0)
K231459Resonance Health Analysis Services Pty Ltd · cleared 2023-06-20 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“HepaFatSmart is an SaMD designed to automatically analyse magnetic resonance imaging (MRI) datasets for quantitative assessment of a patient's liver fat, in form of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grade. It is an AI assisted, automated version of HepaFat-Scan (another SaMD of Resonance Health).”
source quote (p.5)
“It is composed of one (1) convolutional neural network (CNN) performing liver ROI detection with undesired components (artefacts and major blood vessels) considered/removed using a computer vision technique with machine learning technology.”
source quote (p.5)
“Following the training of the AI assisted device, the system is completely 'locked down' for final validation prior to release in commercial use to ensure reproducibility of the results.”
Validation studies (2)
Retrospective clinical
n=41 patients
endpoints: VLFF
Retrospective clinical
n=281 patients
endpoints: VLFF; Sensitivity; Specificity
Reported performance (2 observations)
source quote (p.14)
“100.0 (97.3 - 100.0)”
source quote (p.14)
“98.6 (94.9 - 99.6)”
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).