Cleared Special

K052325 - CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

K052325 is an FDA 510(k) clearance for CYBERKNIFE SYSTEM FOR STEREOTACTIC RADI..., manufactured by Accuray Incorporated. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 20-day FDA review.

K052325 · Accuray Incorporated · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
20d
Days
Class 2
Risk

K052325 is an FDA 510(k) clearance for the CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Accuray Incorporated (Sunnyvale, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 20 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 - K052325

510(k) Number K052325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2005
Decision Date September 14, 2005
Days to Decision 20 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
87d faster than avg
Panel avg: 107d · This submission: 20d
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 K052325.
P.D
K061440 · .Decimal, Inc. · Jun 2006
COHERENCE DOSIMETRIST, MODEL 2.2
K061097 · Siemens Medical Solutions USA, Inc. · Jun 2006
ECLIPSE TREATMENT PLANNING SYSTEM
K050296 · Varian Medical Systems · Nov 2005
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
K051941 · Accuray, Inc. · Aug 2005
VITESSE 2.0
K051497 · Varian Medical Systems, Inc. · Jul 2005
WIMRT MODULE FOR ARTP PLANNING SYSTEM
K041971 · Prodigm Group, Inc. · May 2005