Device typeMulti-modality hyperthermia system: A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using multiple energy sources, for the treatment of malignant or benign tumours, or other disease conditions. It includes a patient-end applicator, software, and a multi-modality generator(s)/control unit. It is intended to achieve whole-body and localized heating of tissues using two or more energy sources [e.g., ultrasound, radio-frequency (RF), microwave, circulating heated fluid] through either externally-mounted components, or from catheter- or probe-type applicators inserted endoscopically or surgically.
FDA categoryMassager, Vacuum, Radio Frequency Induced Heat
Device IDB108284AP01ENUS0100
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information