Myomics
K241922Phantomics Inc. · cleared 2025-02-28 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Myomics is a software application for analysis cardiovascular MR images in DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment.”
source quote (p.4)
“The software comprises various analysis modules, including Al-powered algorithms, for a comprehensive evaluation of MR images. The machine learning algorithms of Myomics were trained and tested using images from various major MR imaging device vendors. Yes (Semi-automatic segmentation)”
source quote (p.9)
“The data used for Al performance testing was not utilized during the algorithm training process.”
Validation studies (2)
Bench
sample size not stated
endpoints: substantial equivalence in performance; compare the semi-automatic segmentation function (endocardium and epicardium contour)
standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019
Retrospective clinical
n=728 cases
endpoints: evaluate the ML model's effectiveness in segmenting the Myocardium; average DICE Score of over 0.7
standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019
Reported performance (1 observation)
source quote (p.9)
“Upon evaluating the performance of each AI module used in Myomics, all modules attained an average DICE Score of over 0.7.”
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).