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.

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
No devices found for this product code.

About Product Code NWE - Regulatory Context