cmAngio® V1.0
K232367CureMetrix, Inc. · cleared 2023-10-05 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms.”
source quote (p.3)
“cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms.”
Validation studies (0)
FDA source did not describe a validation study.
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250754 (decision 2025-04-10) from CureMetrix, Inc. for a matching device line ("cmAngio® (V1.6)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250754
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).