K250392 is an FDA 510(k) clearance for the ZAP-X Radiosurgery System (ZAP-X). This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K250392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |