Identifiers
- 510(k) Number
- K232367 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 V1.0 is an AI-powered software solution designed for breast arterial calcification (BAC) detection and localization on routine screening mammograms. It functions as an adjunct to radiologic interpretation, assisting qualified physicians in identifying and evaluating calcifications within breast arterial structures during mammographic imaging. The device leverages advanced algorithms to enhance detection accuracy and consistency across full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT).
cmAngio V1.0 is supplied as a software application integrated into existing mammography workflows, requiring no additional hardware. It operates as a single-use analytical tool per imaging study, providing real-time BAC detection outputs for radiologic review. The device is FDA-cleared under 510(k) clearance (K232367) and is intended for use in radiology settings by qualified interpreting physicians. No sterility or physical packaging requirements are specified, as it is a digital solution deployed via compatible imaging systems.
Frequently asked questions
How does cmAngio® V1.0 integrate into an existing mammography workflow and what type of imaging systems does it support?
cmAngio® V1.0 integrates seamlessly into existing mammography workflows without requiring additional hardware. It is designed to operate as an adjunct tool on systems that support full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT), enhancing radiologic interpretation by providing real-time breast arterial calcification (BAC) detection outputs for review by qualified physicians.
Is cmAngio® V1.0 a reusable tool or is it intended for single-use per imaging study?
cmAngio® V1.0 is intended for single-use per imaging study. It functions as an analytical tool that provides BAC detection outputs for review during a specific mammographic examination, rather than being reused across multiple studies.
What kind of training or qualifications are required for physicians to use cmAngio® V1.0?
cmAngio® V1.0 is intended for use by *qualified interpreting physicians* in radiology settings. While the device itself does not require additional training beyond standard radiologic interpretation skills, its AI-powered functionality is designed to assist physicians in identifying and evaluating breast arterial calcifications on mammograms, ensuring proper use and interpretation of its outputs.
Does cmAngio® V1.0 require any special storage conditions or physical packaging, like sterility considerations?
No, cmAngio® V1.0 does not have sterility or physical packaging requirements since it is a software-based solution. It is deployed via compatible imaging systems and operates digitally, eliminating the need for traditional storage or handling precautions associated with physical medical devices.
What regulatory pathway was followed for FDA clearance of cmAngio® V1.0, and what does this mean for its use?
cmAngio® V1.0 was cleared through the FDA’s 510(k) process (K232367) under a *Traditional* review pathway, determined to be *Substantially Equivalent* to a predicate device. This means the device meets FDA standards for safety and effectiveness as an adjunct tool for breast arterial calcification detection on FFDM and DBT, intended exclusively for use by qualified physicians in radiology settings.
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, PDF CureMetrix, Inc. Rekha Anand Sr. Director, Regulatory Affairs
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232367 | Class II | Active |
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Manufacturer
- Manufacturer
- Curemetrix, Inc.
Sources (1)
- FDA 510(k) K232367 24 fields · synced Sep 20, 2026