510(k) K250392

ZAP-X Radiosurgery System (ZAP-X) by Zap Surgical Systems, Inc. — Product Code IYE

K250392 is an FDA 510(k) premarket notification submitted by Zap Surgical Systems, Inc. for the device "ZAP-X Radiosurgery System (ZAP-X)". The FDA issued a decision of Substantially Equivalent on November 3, 2025. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Zap Surgical Systems, Inc. has at least 3 other 510(k) clearances on record.