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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 referral of findings related to fibrotic lung disease.
Definition Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
Product CodeQWO
Regulation Number 892.2085
Device Class 2


Premarket Reviews
ManufacturerDecision
IMVARIA, INC
  GRANTED 1

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