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Lung Computed Tomography System, Computer-Aided Detection

FDA product code OEB · 19 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
2003-11-06 – 2026-05-27

To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.

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