Organization name

contextflow GmbH

SRN

AT-MF-000001773

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Caution

  (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

contextflow ADVANCE Chest CT

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

09120107330099

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

912010733CFACHESTCT6J

Reference / catalog number

contextflow ADVANCE Chest CT 2.2

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.