Cleared Traditional

K171804 - Zap-X Radiosurgery System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171804 · Zap Surgical Systems · Radiology device
Sep 2017
Decision
94d
Days
Class 2
Risk

K171804 is an FDA 510(k) clearance for the Zap-X Radiosurgery System. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Zap Surgical Systems (San Carlos, US). The FDA issued a Cleared decision on September 21, 2017 after a review of 94 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K171804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2017
Decision Date September 21, 2017
Days to Decision 94 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 128d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 35
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