NWE · Class II · 21 CFR 892.2050

FDA Product Code NWE: Colon Computed Tomography System, Computer Aided Detection

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.

Leading manufacturers include Siemens AG Medical Solutions, Medicsight and Medicsight Plc.

4
Total
4
Cleared
295d
Avg days
2004
Since

FDA 510(k) Cleared Colon Computed Tomography System, Computer Aided Detection Devices (Product Code NWE)

4 devices
1–4 of 4
Cleared Dec 03, 2014
SYNGO.CT COLONOGRAPHY
K140920
Siemens Medical Solutions USA, Inc.
Radiology · 237d
Cleared May 17, 2011
COLONCAD API 3.1
K083423
Medicsight Plc
Radiology · 909d
Cleared Oct 19, 2004
COLON CAR 1.2
K042674
Medicsight
Radiology · 20d
Cleared Oct 08, 2004
COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K042605
Siemens AG Medical Solutions
Radiology · 14d

About Product Code NWE - Regulatory Context