FDA 510(k) Applications for Medical Device Product Code "NWE"
(Colon Computed Tomography System, Computer Aided Detection)

FDA 510(k) Number Applicant Device Name Decision Date
K042674 MEDICSIGHT COLON CAR 1.2 10/19/2004
K083423 MEDICSIGHT PLC COLONCAD API 3.1 05/17/2011
K042605 SIEMENS AG, MEDICAL SOLUTIONS COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY 10/08/2004
K140920 SIEMENS MEDICAL SOLUTIONS USA, INC. SYNGO.CT COLONOGRAPHY 12/03/2014


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