FDA-cleared K231384

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd.

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...

Modality
CT/CTA
Anatomy
Brain/head
Decision
2023-09-22
FDA-cleared K231767

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2023-09-22
FDA-cleared K231094

Annalise Enterprise CTB Triage-OH

Annalise-AI Pty Ltd

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2023-08-15