CMRtools and its plug-ins VentricularTools and ThalassaemiaTools have FDA 510(k) clearance and carry a Class I CE Mark.
 
 
LVtools, 3Dtools, PerfusionTools are available for research use.
 
What CMRtools can be used for
It is important that CMRtools is only used to view and analyse human cardiac images acquired with a cardiovascular magnetic resonance scanner or test phantom images. The images used must be acquired using one of the approved hardware/software scanner combinations listed on the website www.cmrtools.com. The software must be used in full accordance of the instructions outlined in this document.
 
What CMRtools cannot be used for
CMRtools must not be used to view or analyse images acquired with any scanner other than a cardiovascular magnetic resonance scanner. The software must not be used to view or analyse images of any part of the human body except the heart or the vascular system. Furthermore, the software must not be used to view or analyse images acquired from animals. The software must not be used in a clinical setting outside of its license period. A license can be obtained from sales@cmrtools.com.
 
 
What the VentricularTools can be used for
It is important that VentricularTools is only used to calculate myocardial mass, end-diastolic and end-systolic volume, ejection fraction and stroke volume from magnetic resonance images of the left ventricle in humans. The images used must be acquired using an approved hardware/software scanner combination. The software must be used in full accordance of the instructions outlined in this document.
 
What the VentricularTools cannot be used for
VentricularTools must not be used to calculate parameters for any region of the body except the left and ventricle of the heart. Furthermore, the software must not be used to perform analysis in animals. Finally, the software must not be used to analyse images that have been acquired by any device other than a cardiovascular magnetic resonance scanner.
 
What ThalassaemiaTools can be used for
It is important that ThalassaemiaTools is only used to calculate T2* in the liver or the septal region of the left ventricle of the heart for patients that have or are suspected of having Thalassaemia. The calculated value of T2* must not be treated as a direct measurement of iron loading. The user should be aware that many factors including scanning hardware configuration and imaging artefacts can affect the relationship between iron loading and T2*. As such, the calculated value of T2* should not be the only factor that is taken into account when performing an assessment.
 
What ThalassaemiaTools cannot be used for
ThalassaemiaTools must not be used to calculate any parameter other than T2*. Additionally, it must not be used to calculate T2* in any part of the body other than the liver or the left ventricle. Furthermore, it must not be used to assist in the assessment of any condition other than Thalassaemia. Finally, the software must be used in full accordance of the instructions outlined in this document.
 
 
LVtools, 3Dtools, PerfusionTools are available for research use only. 
CMRtools Regulatory Status
Download FDA 510(k) clearance letter