510(k) K150037

Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities by Sensus Healthcare — Product Code JAD

K150037 is an FDA 510(k) premarket notification submitted by Sensus Healthcare for the device "Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities". The FDA issued a decision of Substantially Equivalent on October 16, 2015. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Sensus Healthcare has at least 6 other 510(k) clearances on record.