Cleared Special

K142219 - GammaBeam 100

K142219 is the FDA 510(k) clearance for GammaBeam 100 by Best Theratronics Limited. It is a Class 2 Radiology device (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)
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.

View all Best Theratronics Limited devices

Submission Details

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
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 22
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