Zap-X Radiosurgery System— 510(k) K171804

Substantially Equivalent

Zap Surgical Systems

FDA 510(k) clearance K171804 for Zap-X Radiosurgery System, Substantially Equivalent on 2017-09-21. Applicant: Zap Surgical Systems.

Clearance details

Applicant: Zap Surgical Systems
Product code: Code IYE
Advisory panel: Radiology
Date received: 2017-06-19
Decision date: 2017-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.