The following data is part of a premarket notification filed by Zap Surgical Systems, Inc. with the FDA for Zap-x Radiosurgical System.
| Device ID | K211663 |
| 510k Number | K211663 |
| Device Name: | Zap-X Radiosurgical System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Zap Surgical Systems, Inc. 590 Taylor Way San Carlos, CA 94070 |
| Contact | Jim Talbot |
| Correspondent | Jim Talbot Zap Surgical Systems, Inc. 590 Taylor Way San Carlos, CA 94070 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-07-29 |