Cleared Special

K072504 - CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

K072504 is an FDA 510(k) clearance for CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM, manufactured by Accuray Incorporated. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 15-day FDA review.

K072504 · Accuray Incorporated · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
15d
Days
Class 2
Risk

K072504 is an FDA 510(k) clearance for the CYBERKNIFE ROBOTIC RADIOSURGERY 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 September 21, 2007 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072504

510(k) Number K072504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2007
Decision Date September 21, 2007
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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

All 679
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K072504.
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MHI-TM2000 LINEAR ACCELERATOR SYSTEM
K072047 · Mitsubishi Heavy Industries, Ltd. · Aug 2007
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K071531 · Accuray Incorporated · Aug 2007