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For more information on the MEDX XRT InteCam® Gamma Camera System please call Eric Ellingson at 800.323.6339 or email sales@medx-inc.com
Click here to learn more about MEDX’s responsive nuclear medicine service options.
MEDX remanufactures the GE 600XR/T Starcam into the MEDX XRT InteCam® System by integrating a state-of-the-art NuQuest® acquisition and processing workstation. This can be done as an upgrade to a nuclear camera currently in the field or can be purchased as a complete system directly from MEDX. The remanufacturing process eliminates many of the original manufacturer’s electronics, reducing potential service calls, and includes a completely new crystal assembly, a rebuilt detector and a new fast, reliable PC. The exclusive MEDX remanufacturing process results in increased performance, better diagnostics and faster nuclear imaging and data processing for all of your nuclear cardiology, general nuclear medicine and whole body procedures.
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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/