Data / Medical devices / United States / Zap Surgical Systems Inc.
Zap Surgical Systems Inc.: FDA-registered device maker in San Carlos, CA, United States, 2 510(k) clearances
Zap Surgical Systems Inc. is registered with the FDA (registration 3012039133) in San Carlos, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 3, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012039133
- Address
- 590 Taylor Way, San Carlos, CA, United States, 94070
- Owner or operator
- Zap Surgical Systems Inc. (10058325)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 6, 2023
- Registered through
- 2026
- Brand names listed
- ZAP-X Radiosurgery System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 3, 2025 | K250392 | ZAP-X Radiosurgery System (ZAP-X) | IYE | Substantially Equivalent | Zap Surgical Systems, Inc. | accessdata.fda.gov |
| July 29, 2021 | K211663 | Zap-X Radiosurgical System | IYE | Substantially Equivalent | Zap Surgical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 25, 2025 | 97413 | Class II | Ongoing | ZAP-X Radiosurgery System, Model: 300150 | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table. | accessdata.fda.gov |
| July 5, 2022 | 90716 | Class II | Ongoing | ZAP-X Radiosurgery System | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position f | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of System, Planning, Radiation Therapy Treatment
Updated November 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.