Refurbished Nuclear Medicine Equipment
MEDX is a genuine nuclear medicine camera remanufacturer. Because of this, we are regularly inspected to certify all of our remanufacturing processes meet FDA QSR and GMP regulations. We utilize these regulated processes when we refurbish a piece of nuclear medicine equipment as well. We guarantee that your MEDX refurbished gamma camera will meet the original manufacturer’s specifications ensuring you will only receive safe and high-quality equipment.
We are so confident in our refurbishing process that we back all of our refurbished nuclear cameras with a full, one-year parts and labor warranty and a three-year crystal warranty.
Click on a gamma camera below for more information:
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Click here to learn more about MEDX’s responsive 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/