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Colon Computed Tomography System, Computer Aided Detection

FDA product code NWE · 3 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2050
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-10-08 – 2011-05-17

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.

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