Annalise-AI radiology AI products

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Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

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Radiology AI pricing and total cost of ownership

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FDA-cleared K250831

Annalise Enterprise

Annalise-AI

Authorized purpose: Triage and prioritization of adult CXR and non-contrast brain CT studies for specified suspected findings, including pneumoperitoneum, pleural effusion, pneumothorax and tension pneumothorax on CXR, and acute extra-axial hemorrhage, subarachnoid hemorrhage, intra-axial hemorrhage, intraventricular hemorrhage, mass effect, obstructive hydrocephalus and vasogenic edema on brain CT.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Chest/Lung; Brain
Decision: 2025-04-23

Stroke and ICH triage Acute triage and notification

FDA-cleared K213941

Annalise Enterprise CXR Triage Pneumothorax

Annalise-AI

Authorized purpose: Aids assessment and worklist triage of adult chest x-rays with suspected pneumothorax or tension pneumothorax.

Modality: X-ray/Radiography
Anatomy: Chest
Decision: 2022-02-24

Acute triage and notification