K250392
- 510(k) number
- K250392
- Device name
- ZAP-X Radiosurgery System (ZAP-X)
- Applicant
- Zap Surgical Systems, Inc. CA · US
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2025-11-03
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250392.pdf
Official FDA record: K250392
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.