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6 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Annalise-AI Pty Ltd.
Authorized purpose: Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out tool.
Annalise-AI Pty Ltd
Authorized purpose: Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of vasogenic edema by providing study-level output to an order and imaging management system; the notification is not for standalone clinical decision-making or to rule out the finding.
Annalise-AI Pty Ltd
Authorized purpose: Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of obstructive hydrocephalus by providing study-level output to an order and imaging management system; the notification is not for standalone clinical decision-making or to rule out the finding.
Annalise-AI Pty Ltd
Authorized purpose: Triage and prioritization of adult CTB studies suggestive of acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, or intraventricular hemorrhage; the findings are intended to be used together.
Annalise-AI Pty Ltd
Authorized purpose: Triage and prioritization of adult chest X-ray cases suggestive of pleural effusion or pneumoperitoneum.
Annalise-AI Pty Ltd
Authorized purpose: Triage and prioritization of adult chest X-ray cases suggestive of vertebral compression fracture, including use in Bone Health and Fracture Liaison Service programs.