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NWE — Colon Computed Tomography System, Computer Aided Detection Class II

FDA Device Classification

Classification Details

Product Code
NWE
Device Class
Class II
Regulation Number
892.2050
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140920siemens medical solutions usaSYNGO.CT COLONOGRAPHYDecember 3, 2014
K083423medicsightCOLONCAD API 3.1May 17, 2011
K042674medicsightCOLON CAR 1.2October 19, 2004
K042605siemens ag medical solutionsCOLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYOctober 8, 2004