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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeSAO
Regulation Number 892.1171
Device Class 2


Premarket Reviews
ManufacturerDecision
16 BIT INC
  GRANTED 1

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