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cmAngio

Curemetrix, Inc. · Model V1.6 · UDI-DI 00860006442699

QIH Prescription

510(k) clearances

Adverse events

Recalls

242

Facilities

Description

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). 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. The device also marks BAC segments on thumbnails of images for localization of BAC. The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.

Recalls

Date	Firm	Reason
2026-05-07	PIE Medical Imaging B.V.	User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d
2021-05-19	Caption Health	The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.