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Sign in to claim this brandCircle Cardiovascular Imaging
US
Last updated September 17, 2026
What Circle Cardiovascular Imaging makes
Circle Cardiovascular Imaging develops specialized software applications for MRI and CT imaging systems, focusing on cardiac and myocardial analysis. Their products include tools for cardiac CT function assessment, myocardial strain evaluation, and treatment planning, such as TruPlan. These applications are designed to enhance diagnostic capabilities for cardiovascular imaging studies.
The company’s portfolio consists of Class II medical devices, regulated under FDA pathways including 510(k) premarket notifications and the Unique Device Identifier (UDI) system. Their software applications are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device authorization requirements. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Circle Cardiovascular Imaging manufacture?
Circle Cardiovascular Imaging specializes in developing software applications for MRI and CT imaging systems. Their primary focus is on cardiovascular and myocardial analysis, including tools for cardiac CT function assessment, myocardial strain evaluation, and treatment planning. Examples of their products include software like TruPlan, Cardiac CT Function Software Application, and Myocardial Strain Software Application.
Where is Circle Cardiovascular Imaging based?
Circle Cardiovascular Imaging is based in the United States. The company operates from within the country, where its products are designed, developed, and authorized for use.
Which regulatory registries or databases list Circle Cardiovascular Imaging’s devices?
Circle Cardiovascular Imaging’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification pathway and the Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. medical device authorization requirements for their Class II software applications.
How are Circle Cardiovascular Imaging’s devices classified under FDA regulations?
Circle Cardiovascular Imaging’s devices fall under the classification of Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device, and it requires compliance with specific regulatory controls, including premarket notifications (510(k)) and UDI requirements.
What is the purpose of Circle Cardiovascular Imaging’s software applications in medical imaging?
Circle Cardiovascular Imaging’s software applications are designed to enhance diagnostic capabilities for cardiovascular imaging studies. They provide specialized tools for analyzing cardiac function, assessing myocardial strain, and aiding in treatment planning, such as with TruPlan. These applications integrate with MRI and CT systems to improve accuracy and efficiency in evaluating heart-related conditions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| cvi42 | 5.x | FDA UDI | Class II | Active |
| cvi42 | 5.6 | FDA UDI | Class II | Active |
| TruPlan | 1.x | FDA UDI | Class II | Active |
| Cardiac CT Function Software Application | K241038 | FDA 510(k) | Class II | Active |
| Myocardial Strain Software Application | K232661 | FDA 510(k) | Class II | Active |
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