Pure Global

Automated Radiological Image Processing Software

Automated Radiological Image Processing Software 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
Automated Radiological Image Processing Software
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QIH

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Class 2

21 CFR 892.2050

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Radiology

Device Characteristics

No

No

No

Not Eligible

Definition

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.