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Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

FDA product code SAO · 2 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1171
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-09-02 – 2026-06-10

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.

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