Myomics

K241922

Phantomics Inc. · cleared 2025-02-28 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The software comprises various analysis modules, including AI-powered algorithms, for a comprehensive evaluation of MR images.”
AlgorithmAI-powered algorithms for semi-automatic segmentation using Machine Learning technique
source quote (p.4)
“The software comprises various analysis modules, including AI-powered algorithms, for a comprehensive evaluation of MR images.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: verify the substantial equivalence in performance between the subject device (Myomics) and the predicate device (Myomics Q); compare the semi-automatic segmentation function (endocardium and epicardium contour) between the subject device (Myomics) and the secondary predicate device (cvi42 auto)

Retrospective clinical

n=728 images

endpoints: evaluate the ML model's effectiveness in segmenting the Myocardium; attained an average DICE Score of over 0.7

Reported performance (1 observation)

diceas written: “average DICE Score”0.7
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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K241922