Name: Predicase
Price: 199 USD

K-number	K250392
Device name	ZAP-X Radiosurgery System (ZAP-X)
Applicant	Zap Surgical Systems, Inc.
Product code	IYE
Device class	Class II
Decision date	Nov 3, 2025
Decision	Substantially Equivalent
Regulation	892.5050

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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ZAP-X Radiosurgery System (ZAP-X)

Everything you need for a 510(k) submission. Nothing you don't.