ZAP-X Radiosurgery System (ZAP-X)
FDA 510(k) K250392 · Zap Surgical Systems, Inc.
510(k) numberK250392
Submission
- Device name
- ZAP-X Radiosurgery System (ZAP-X)
- Applicant
- Zap Surgical Systems, Inc.
San Carlos, CA, US - Received
- February 12, 2025
- Decision date
- November 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ZAP-X Radiosurgery System (ZAP-X) cleared by the FDA?
ZAP-X Radiosurgery System (ZAP-X) (K250392) received a 510(k) decision of Substantially Equivalent on November 3, 2025, 264 days after the submission was received.
What is the product code of K250392?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.