The following data is part of a premarket notification filed by Zap Surgical Systems with the FDA for Zap-x Radiosurgery System.
| Device ID | K171804 |
| 510k Number | K171804 |
| Device Name: | Zap-X Radiosurgery System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Zap Surgical Systems 590 Taylor Way Suite A San Carlos, CA 94070 |
| Contact | Radhika Mohan Bodduluri |
| Correspondent | Darlene Crockett-billig Experien Group, LLC 224 Airport Parkway Suite 250 San Jose, CA 95110 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2017-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860183001535 | K171804 | 000 |
| 00860183001528 | K171804 | 000 |
| 00860183001511 | K171804 | 000 |
| 00860183001504 | K171804 | 000 |