Pure Global

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density 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
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Radiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

SAO

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Class 2

21 CFR 892.1171

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Radiology

Device Characteristics

No

No

No

Not Eligible

Definition

This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.