2 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
FDA Enforcement
Class II
·Terminated·Carestream Health, Inc.·February 5, 2014
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
FDA Enforcement
Class II
·Terminated·Carestream Health, Inc.·January 29, 2014