Cleared Special

K060314 - ROTATING GAMMA SYSTEM. GAMMA ART-6000

K060314 is an FDA 510(k) clearance for ROTATING GAMMA SYSTEM. GAMMA ART-6000, manufactured by American Radiosurgery, Inc.. The device is a Class 2 Radiology device with product code IWB cleared through the Special 510(k) pathway after a 57-day FDA review.

K060314 · American Radiosurgery, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
57d
Days
Class 2
Risk

K060314 is an FDA 510(k) clearance for the ROTATING GAMMA SYSTEM. GAMMA ART-6000. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by American Radiosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on April 6, 2006 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5750 - 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 - K060314

510(k) Number K060314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2006
Decision Date April 06, 2006
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

IWB Device Classification - Class 2, Special Controls

Product Code IWB System, Radiation Therapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5750
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 - IWB System, Radiation Therapy, Radionuclide

All 41
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K060314 · ROTATING GAMMA SYSTEM. GAMMA ART-6000
Download PDF FDA Summary American Radiosurgery…