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Chest / ThoracicUS + EU

Annalise Enterprise CXR

πŸ‡¦πŸ‡ΊAnnalise.ai Β· Lesion detection/diagnosis software

What it does

Flags a range of findings on chest radiographs to support the radiologist's read, highlighting areas to look at across many possible findings.

Who it's for

General and chest radiologists reading high volumes of chest X-rays who want a detection aid.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics β€” 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 #β€”
Product codeQFM
Decision dateFeb 1, 2023
PanelRadiology

EU (CE)

StatusCE-marked
Risk classβ€”
Notified bodyβ€”
EMDN codeβ€”
Basic UDI-DIβ€”
AI Act classβ€”

Vendor

Founded2019 Β· via manual

Cite this page

RadPigeon. "Annalise Enterprise CXR (Annalise.ai)." AI Devices registry. https://radpigeon.news/ai/device/annalise-enterprise-cxr

Last updated Jun 29, 2026 Β· last verified Jun 29, 2026. Information only β€” not clinical advice. Summaries are RadPigeon's own wording.