Home » Harmonus’ ProBx Software Granted 510(k) Clearance
Harmonus’ ProBx Software Granted 510(k) Clearance
Devices Submissions and Approvals
The FDA gave Harmonus’ ProBx software 510(k) clearance for use in MRI-guided prostate interventions.
The software targets and confirms suspicious lesions and creates a detailed record of sampling locations, allowing the doctor to monitor the lesions and treat them.
It is attached to an MRI console and receives DICOM images that can be displayed in both 2D and 3D for patients and doctors.