Cleared Traditional

K150873 - CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System (FDA 510(k) Clearance)

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

K150873 · Accuray Incorporated · Radiology device
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Jul 2015
Decision
91d
Days
Class 2
Risk

K150873 is an FDA 510(k) clearance for the CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Accuray Incorporated (Sunnyvale, US). The FDA issued a Cleared decision on July 1, 2015 after a review of 91 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.

View all Accuray Incorporated devices

Submission Details

510(k) Number K150873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2015
Decision Date July 01, 2015
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
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

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