MEDX Nuclear Medicine Equipment
MEDX’s Certified® Refurbishing Process ensures your equipment is of the highest quality, meets the strictest standards and allows for the highest return on your investment. As an FDA-registered remanufacturer of gamma cameras, the rules and regulations set forth by FDA apply to every camera system that leaves our manufacturing facility. Click on a gamma camera below for more information:
Single, Circular Detector for Cardiac Imaging Single, Circular Detector for Cardiac Imaging Single, Rectangular Detector for All-Purpose Imaging Single, Circular Detector for Mobile Imaging Single, Circular Detector for Low-Energy Imaging
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“A remanufacturer as defined in 21 CFR 820.3 (w) is any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that changes the finished device's performance or safety specifications or intended use. Remanufacturers are considered manufacturers. As such, these manufacturers are subject to inspection by FDA and shall meet the applicable requirements of the medical device QS regulation. These manufacturers shall establish and implement quality systems to assure the safety and effectiveness of the devices that are distributed…”
Source: Good Manufacturing Practices (GMP)/Quality System Regulation. 2004 U.S. Food and Drug Administration. 28 Jan 2004. http://www.fda.gov/CDRH/DEVADVICE/32.html/
