Cleared Traditional

K250392 - ZAP-X Radiosurgery System (ZAP-X)
(FDA 510(k) Clearance)

K250392 · Zap Surgical Systems, Inc. · Radiology

Nov 2025

Decision

264d

Days

Class 2

Risk

K250392 is an FDA 510(k) clearance for the ZAP-X Radiosurgery System (ZAP-X), a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Zap Surgical Systems, Inc. (San Carlos, US). The FDA issued a Cleared decision on November 3, 2025, 264 days after receiving the submission on February 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K250392 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2025
Decision Date	November 03, 2025
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF