contextflow ADVANCE Chest CT 2.0

Organization name

contextflow GmbH

SRN

AT-MF-000001773

Manufacturer status

Active

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• CW011

  (1) Results provided by the system could contribute to image interpretation errors which in turn could contribute to an incorrect diagnosis of a patient's condition that leads to wrong treatment and ultimately causes a patient harm. (2)The system can generate incorrect outputs (within the system's performance specifications) that are potentially misleading to users such as - inaccurate detection of lung anomalies - incorrect recommendations of image patterns (3) Lists of possible diagnosis associated with specific image patterns provided by the system are not ranked by relevance (4) System does not provide image analysis results for any anatomies other than lung tissue.

Primary placement in Austria; available across 17 countries total.

Trade name

not provided

UDI-DI code

09120107330075

Basic UDI-DI

912010733CFACHESTCT6J

Reference / catalog number

contextflow ADVANCE Chest CT 2.0

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

contextflow ADVANCE Chest CT is an AI-based, Computer Aided Detection (CADe) system for 3D medical imaging data. It provides qualitative and quantitative analysis results and corresponding reference information relevant for the identification and interpretation of lung-specific image patterns in CT (Computed Tomography) scans. To that end, the system provides the following functionalities: - SEARCH Qualitative image analysis results based on selected image regions. Visual image retrieval from a knowledge base of expert-labeled retrospective cases and pattern classification - INSIGHTS Quantitative image analysis results by automated detection, quantification and visualization of lung anomalies, specific image patterns and lung nodules - TIMELINE Longitudinal analysis of quantitative image analysis results for lung nodules and visualizations for progression or regression. - Reference Information Links to literature, articles or guidelines, tips and pitfalls, and differential diagnosis candidates

Additional information URL

https://contextflow.com/

Clinical sizes

No clinical sizes registered for this device.

• Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

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