Cleared Traditional

K250392 - ZAP-X Radiosurgery System (ZAP-X)

K250392 is an FDA 510(k) clearance for ZAP-X Radiosurgery System (ZAP-X), manufactured by Zap Surgical Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K250392 · Zap Surgical Systems, Inc. · Radiology device
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Nov 2025
Decision
264d
Days
Class 2
Risk

K250392 is an FDA 510(k) clearance for the ZAP-X Radiosurgery System (ZAP-X). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Zap Surgical Systems, Inc. (San Carlos, US). The FDA issued a Cleared decision on November 3, 2025 after a review of 264 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zap Surgical Systems, Inc. devices

FDA 510(k) Submission Details - K250392

510(k) Number K250392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2025
Decision Date November 03, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 107d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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