Cleared Special

K091146 - MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

K091146 is an FDA 510(k) clearance for MODIFICATION TO CYBERKNIFE ROBOTIC RADI..., manufactured by Accuray, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 11-day FDA review.

K091146 · Accuray, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
11d
Days
Class 2
Risk

K091146 is an FDA 510(k) clearance for the MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Accuray, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 1, 2009 after a review of 11 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 - K091146

510(k) Number K091146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date May 01, 2009
Days to Decision 11 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
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
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 - MUJ System, Planning, Radiation Therapy Treatment

All 256
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K091146.
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K083414 · Integra Radionics, Inc. · Mar 2009
K091146 · MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Download PDF FDA Summary Accuray, Inc.