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Radiological Computer-Assisted Prioritization Software For Lesions

Radiological Computer-Assisted Prioritization Software For Lesions 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
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Radiological Computer-Assisted Prioritization Software For Lesions
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QFM

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Class 2

21 CFR 892.2080

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Radiology

Device Characteristics

No

No

No

Not Eligible

Definition

Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.