Identifiers
- 510(k) Number
- K250754 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
cmAngio (V1.6) is an AI-enabled medical device designed for breast arterial calcification detection and localization on routine screening mammograms. It helps radiologists detect, quantify, and contextualize breast arterial calcifications on both FFDM and DBT mammogram types.
The device is supplied as software and integrates into existing radiology workflows. It has received FDA 510(k) clearance (K250754) with a final decision on 2025-04-10, reviewed by the Radiology advisory committee. The device is intended for use at clinical sites to support consistent identification and reporting of breast arterial calcifications.
Frequently asked questions
What is cmAngio® (V1.6) used for?
cmAngio® (V1.6) is designed to detect, quantify, and localize breast arterial calcifications on routine screening mammograms, supporting radiologists in identifying and reporting these findings on both FFDM and DBT image types to improve consistency in clinical assessment.
How is cmAngio® (V1.6) supplied and integrated into clinical use?
The device is supplied as software that integrates directly into existing radiology workflows, allowing seamless use at clinical sites without requiring additional hardware, and is intended to assist radiologists during routine mammogram interpretation.
Is cmAngio® (V1.6) a single-use or reusable device?
As a software-based medical device, cmAngio® (V1.6) is not subject to physical wear or single-use limitations; it can be used repeatedly for image analysis as part of ongoing clinical workflows, with no inherent restriction on the number of analyses performed.
What regulatory clearance does cmAngio® (V1.6) have?
cmAngio® (V1.6) has received FDA 510(k) clearance under submission number K250754, with a final decision issued on April 10, 2025, following review by the Radiology advisory committee, confirming its substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cmAngio® — CureMetrix FDA-Cleared BAC Detection AI, CureMetrix cmAngio FDA Cleared AI for Mammography, CureMetrix, Inc.: cmAngio® (V1.6) (FDA-cleared AI medical device), Curemetrix, Inc. FDA 510 (k) Products - Latest 2026
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250754 | Class II | Active |
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Manufacturer
- Manufacturer
- Curemetrix, Inc.
Sources (1)
- FDA 510(k) K250754 24 fields · synced Sep 22, 2026