510(k) K211663 ยท IYE Accelerator, Linear, Medical
Zap-X Radiosurgical System
| Applicant | Zap Surgical Systems, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Jul 29, 2021 |
| Received | Jun 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211663
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2025 | Zap Surgical Systems ZAP-X Radiosurgery System, Model: 300150 Open, Classified |
IYE | None listed |
| Jul 5, 2022 | Zap Surgical Systems ZAP-X Radiosurgery System Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.