Chest / ThoracicUS + EU
Annalise Enterprise CXR
π¦πΊAnnalise.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
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.
