FDA Expands 510(k) Clearance for MRI Contrast Injection System
The MEDRAD MRXperion MR Injection System is cleared for use with low-field and high-field MRI platforms, including 7T MRI.
The Food and Drug Administration (FDA) has granted an expanded 510(k) clearance for the use of the MEDRAD® MRXperion MR Injection System.
Designed for contrast-enhanced MRI exams, the piston technology power injector can now be utilized in a variety of low-field and high-field MRI settings, including 7T MRI, according to Bayer, the manufacturer of the
The company also pointed out the addition of the Imaging Scanner Interface 2 to the MEDRAD® MRXperion MR Injection System for enhancing efficiencies and coordination with MRI exams.
“MRXperion already has a strong track record of delivering dependable imaging performance across clinical settings, and this clearance reinforces and expands on its established reputation as a flexible solution that supports coordinated, efficient workflows across MR systems,” noted Jill Carbone, vice president and head of radiology North America Product & Pipeline at Bayer.
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