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U.S. Department of Health and Human Services

Product Classification

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Device radiology software for opportunistic evaluation of low bone mineral density
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.
Physical State Software device that receives radiological image data as an input and identifies patients with possibly low BMD. It cannot be used to rule out low BMD.
Technical Method Analyzes radiological data using locked image processing algorithm to estimate BMD values. Software may implement artificial intelligence algorithms. The algorithm training data typically impacts device performance.
Target Area Human-derived radiological imaging products.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeSAO
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.1171
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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