Cleared Special

K142219 - GammaBeam 100

K142219 is an FDA 510(k) clearance for GammaBeam 100, manufactured by Best Theratronics Limited. The device is a Class 2 Radiology device with product code IWB cleared through the Special 510(k) pathway after a 93-day FDA review.

K142219 · Best Theratronics Limited · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
93d
Days
Class 2
Risk

K142219 is an FDA 510(k) clearance for the GammaBeam 100. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Best Theratronics Limited (Ottawa, CA). The FDA issued a Cleared decision on November 13, 2014 after a review of 93 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K142219

510(k) Number K142219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2014
Decision Date November 13, 2014
Days to Decision 93 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
14d faster than avg
Panel avg: 107d · This submission: 93d
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 47
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K142219.
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LEKSELL GAMMA KNIFE PERFEXION
K133565 · Elekta Instrument AB · May 2014
HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
K131777 · Hyper Technology, Inc. · Feb 2014
LEKSELL GAMMA KNIFE PERFEXION
K120811 · Elekta Instrument AB · May 2012
K142219 · GammaBeam 100
Download PDF FDA Summary Best Theratronics Lim…