Cleared Special

K062967 - CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

K062967 is an FDA 510(k) clearance for CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM, 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 31-day FDA review.

K062967 · Accuray, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
31d
Days
Class 2
Risk

K062967 is an FDA 510(k) clearance for the 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 October 30, 2006 after a review of 31 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.

View all Accuray, Inc. devices

FDA 510(k) Submission Details - K062967

510(k) Number K062967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date October 30, 2006
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
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 166
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K062967.
MONACO RTP SYSTEM
K071938 · Computerized Medical Systems, Inc. · Oct 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873 · Varian Medical Systems, Inc. · Aug 2007
CROSSPLAN / ACCUSOFT-XL V.4.04
K063482 · Direx Systems Corp. · Dec 2006
ACCUSOFT, ACCUSOFT XL
K062032 · Direx Systems Corp. · Oct 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062514 · Accuray Incorporated · Sep 2006
IPLAN RT DOSE
K053584 · Brainlab AG · Jul 2006