510(k) K131582

SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM by Sensus Healthcare — Product Code JAD

K131582 is an FDA 510(k) premarket notification submitted by Sensus Healthcare for the device "SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 28, 2013. 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.