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Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd · Lesion detection/diagnosis software

What it does

Marks areas of interest on multi-modality images to support the radiologist's read as a second pair of eyes; the radiologist makes the call.

Who it's for

Radiologists who want a detection aid on these studies and programs aiming to improve consistency.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)
Submission #K222179
Product codeQFM
Decision dateMar 28, 2023
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk class
Notified body
EMDN code
Basic UDI-DI
AI Act class

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Foundedunknown

Cite this page

RadPigeon. "Annalise Enterprise CXR Triage Trauma (Annalise-AI Pty Ltd)." AI Devices registry. https://radpigeon.news/ai/device/annalise-enterprise-cxr-triage-trauma

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.