SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100

SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 is an FDA 510(k)-cleared medical device (K123985) manufactured by Sensus Healthcare. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 2013. Regulation: 8.