LiverSmart

K213776

Resonance Health Analysis Services Pty Ltd · cleared 2021-12-29 · product code PCS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“LiverSmart is software that utilizes two existing FDA cleared devices, HepaFat-AI(K201039) and FerriSmart (K182218) and combines their respective results into a singular consolidated multi-parametric 'LiverSmart' report.”

AlgorithmConvolutional neural networks for the image analysis. Algorithmic for the image's quality checks, R2 conversion into LIC, and Alpha conversion into VLFF.

source quote (p.8)

“Convolutional neural networks for the image analysis. Algorithmic for the image's quality checks, R2 conversion into LIC, and Alpha conversion into VLFF.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).