TruPlan Computed Tomography (CT) Imaging Software
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222593 FDA 510(k)
- FDA Product Code
- LLZ 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)
TruPlan Computed Tomography (CT) Imaging Software is a medical imaging application designed for planning and guiding interventional procedures using CT scan data. It integrates with radiology workflows to enhance visualization, measurement, and navigation capabilities for clinicians performing complex interventions such as coronary artery interventions or structural heart procedures.
The software is supplied as a digital product for use in radiology departments and interventional labs, requiring compatibility with existing CT imaging systems. It is intended for single-use per session, though the underlying software license may allow repeated use across multiple procedures. No sterility or physical packaging requirements apply, as it operates on hospital networks and workstations. Authorized under FDA 510(k) clearance (K222593) and MDR compliance, it adheres to regulatory standards for radiology software without specific MRI safety classifications.
Frequently asked questions
What types of medical procedures is this software designed to assist with during CT imaging sessions?
TruPlan CT Imaging Software is specifically designed to support clinicians during complex interventional procedures, such as coronary artery interventions and structural heart procedures. It integrates with CT scan data to enhance visualization, measurement, and navigation, helping guide interventions more precisely in radiology and interventional labs.
How is TruPlan CT Imaging Software supplied, and does it require any physical packaging or sterility considerations?
TruPlan is supplied as a digital product, meaning it is not packaged in physical materials like traditional medical devices. Since it operates on hospital networks and workstations, there are no sterility requirements or physical packaging considerations—it is purely software-based.
Is this software intended for single-use or repeated use across multiple procedures?
The software is intended for single-use per session, aligning with typical workflows for interventional planning. However, the underlying software license may allow repeated use across multiple procedures, meaning it can be utilized in different sessions as long as the licensing terms are followed.
What kind of compatibility does TruPlan require with existing hospital systems?
TruPlan is designed to integrate with existing CT imaging systems and radiology workflows. While specific hardware or software compatibility details are not provided, its digital nature suggests it should work with standard hospital networks and workstations used for radiology and interventional procedures.
How does TruPlan ensure compliance with regulatory standards, and what does its FDA clearance mean for hospitals?
TruPlan holds FDA 510(k) clearance (K222593) and complies with the Medical Device Regulation (MDR), meaning it has undergone evaluation to demonstrate substantial equivalence to a predicate device. For hospitals, this clearance indicates the software meets regulatory safety and performance standards for use in radiology and interventional settings, though it does not imply any specific clinical indication beyond its intended procedural support.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222593 | Class II | Active |
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Manufacturer
- Manufacturer
- Circle Cardiovascular Imaging Inc
- FDA Applicant
- Circle Cardiovascular Imaging, Inc.
Sources (2)
- FDA 510(k) K222593 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026