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 Medicsight, Siemens Medical Solutions USA, Inc. and Siemens AG Medical Solutions.

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 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