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Lung Computed Tomography System, Computer-Aided Detection

Lung Computed Tomography System, Computer-Aided Detection is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Lung Computed Tomography System, Computer-Aided Detection
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OEB

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Class 2

21 CFR 892.2050

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Radiology

Device Characteristics

No

No

No

Not Eligible

Definition

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.