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Imaging Sciences International, LLC

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Rad recall (Z-2463-2012)Imaging Sciences International, LLC2012-09-26
i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a th recall (Z-3018-2011)Imaging Sciences International, LLC2011-08-12
i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Ha recall (Z-0543-2010)Imaging Sciences International, LLC2009-12-17
Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufact recall (Z-1265-2009)Imaging Sciences International, LLC2009-05-22

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Every clearance here is in the API, with alerts when new ones post.