"MRI compatibility and visibility assessment of implantable medical devices." J Magn Reson Imaging 9(4):596-603.Schueler BA, Parrish TB, Lin J, Hammer BE, Pangrle BJ, Ritenour ER, Kucharczyk J, Truwit CL. MRI compatibility and visibility assessment of implanta- ble medical devices. J Magn...
( a previous version of t he device) has been evaluat ed t hrough bench t est ing in MRI syst ems wit h st at ic fields of ≤1. 5 Tesla, gradient magnet ic fields of ≤20 Tesla/ second and whole body averaged specific absorpt ion rat e ( SAR) of 1. 2 W/ kg for 30 ...
to determine the safety and compatibility with potential recipients; 5. to predict treatment response or reactions; 6. to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be IVD medical devices.” A“specimen receptacle” is defined as “a device, whether of...
Our Comprehensive Medical Device Testing Services comprise the following: With more than 100 years of product safety and electromagnetic compatibility expertise, we can help you navigate complexities in medical device compliance. From testing & certification to global market access, we help you bring you...
View our Medical Device Training Courses. View Our Services Biocompatibility Testing Assess the compatibility of medical devices with a biological system Learn More Electrical Safety Testing (IEC 60601) Testing is a critical step in the process of transforming an innovative design into a reliable and ...
View our Medical Device Training Courses. View Our Services Biocompatibility Testing Assess the compatibility of medical devices with a biological system Learn More Electrical Safety Testing (IEC 60601) Testing is a critical step in the process of transforming an innovative design into a reliable an...
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Draft guidance document, available for public comment for 60 days, provides suggested standards for testing and labeling of medical devices meant to function in an MRI environment
An optical sense signal generator for medical device's having a photonic catheter containing optical conductors conducting light energy in two directions between electronics at a catheter proximal end
A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodim