Certified Pre-Owned Nuclear Medicine Equipment
MEDX takes pride in every piece of nuclear medicine equipment that leaves our manufacturing facility. Following a strict set of quality control processes ensures that we produce only the highest quality gamma cameras. Most nuclear medicine cameras include one-year warranties and our own service team provides several service options to ensure lasting success.
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Click here to learn more about MEDX’s responsive nuclear medicine service options.
“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/