FerriSmart Analysis System
K182218Resonance Health Analysis Services Pty Ltd · cleared 2018-11-30 · product code PCS · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“FerriSmart is a stand-alone software application that automatically analyses multi-slice, spin-echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo. The software application is a measuring medical device intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.”
source quote (p.5)
“FerriSmart AI Analysis Software: Custom-designed image analysis software performing the R2 measurement based on AI (Artificial Intelligence) technology. Convolutional neural networks for the image analysis. Algorithmic for the images quality checks and R2 conversion into LIC.”
Validation studies (3)
Bench
sample size not stated
endpoints: usability; readability of the patient report; Instructions for Use
Bench
n=60 patients
endpoints: precision of FerriSmart
Retrospective clinical
n=971 other
endpoints: Assessing the performance of the FerriSmart IQC module; Assessing the bias and limits of agreement between FerriSmart and FerriScan measurements of LIC on multiple scanners; Assessing the diagnostic performance of FerriSmart for predicting FerriScan LIC results above various clinically relevant LIC thresholds on multiple scanners
standards: EN ISO 14971:2012 – Medical Devices – Application of Risk Management to Medical Devices
Reported performance (2 observations)
source quote (p.10)
“96 (94-97)”
source quote (p.10)
“80 (73-87)”
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 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).