TeraRecon Cardiac.Chambers.MR (1.0.0)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241312 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)
The TeraRecon Cardiac.Chambers.MR (1.0.0) is a medical imaging software tool designed for cardiac chamber segmentation and analysis in magnetic resonance imaging (MRI). It automates the identification and quantification of left and right ventricular chambers, enabling precise volumetric and functional assessments of cardiac structures from MRI scans.
This software is supplied as a standalone application for use in clinical or research settings with MRI-compatible systems. It operates on MRI-compatible workstations and is intended for single-use per imaging session, though the software license may allow repeated use across multiple scans. The device holds FDA 510(k) clearance under Traditional review and is also compliant with the EU Medical Device Regulation (MDR), with no specific sterility or reusable components required.
Frequently asked questions
What specific cardiac assessments does this software automate in MRI scans, and how does it differ from manual analysis?
The TeraRecon Cardiac.Chambers.MR (1.0.0) automates the segmentation and quantification of left and right ventricular chambers in MRI scans, providing precise volumetric and functional assessments. Unlike manual analysis, which requires clinicians to delineate cardiac structures frame-by-frame, this software streamlines the process by identifying and measuring these chambers automatically, improving efficiency and reducing variability in measurements.
Is this software designed for clinical use only, or can it also be used in research settings?
The software is explicitly supplied for both clinical and research settings, as stated in its description. It is intended for use with MRI-compatible systems and can support workflows in either environment, though its primary purpose remains cardiac chamber analysis in MRI scans.
How is the software licensed for use, and does it allow repeated use across multiple imaging sessions?
The software is supplied as a standalone application and is intended for single-use per imaging session in terms of its physical or procedural workflow. However, the software license itself permits repeated use across multiple scans, meaning the same software installation can be utilized for different MRI sessions without requiring re-installation or re-licensing.
What type of MRI-compatible workstations does this software require for operation?
The software operates on MRI-compatible workstations, but the specific hardware requirements (e.g., operating system, minimum specs) are not detailed in the provided data. It is designed to integrate with existing MRI systems used in clinical or research settings, so compatibility would depend on the workstation’s software environment and the MRI vendor’s system.
What regulatory pathways has this device undergone, and how does that affect its adoption in the US and EU?
The software holds FDA 510(k) clearance under Traditional review (K241312) and is compliant with the EU Medical Device Regulation (MDR). This means it is legally marketable in the US and EU markets under these respective regulatory frameworks, though adoption may still depend on institutional policies, IT integration, and local MRI workflows.
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 | K241312 | Class II | Active |
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Manufacturer
- Manufacturer
- Terarecon Inc.
- FDA Applicant
- Terarecon,Inc.
Sources (2)
- FDA 510(k) K241312 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026