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2 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Milvue
Authorized purpose: Aids clinicians and radiologists reviewing 2D X-ray radiographs by detecting, localizing, and characterizing fractures across the FDA-listed appendicular, hip/pelvis, clavicle, and thorax/rib examinations, and by detecting elbow joint effusion on lateral elbow or forearm views in children/adolescents and adults; results are not standalone clinical decisions.
Milvue
Authorized purpose: Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22 years and older; not diagnostic or a rule-out function.