Zap-X Radiosurgical System

Zap-X Radiosurgical System is an FDA 510(k)-cleared medical device (K211663) manufactured by Zap Surgical Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2021. Regulation: 8.