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Organization name
UDI-DI code
Reference / catalog number

contextflow SERACH Lung CT — Class IIa MDR by contextflow GmbH

MD Atlas
contextflow GmbH

EUDAMED last updated this device on Apr 26, 2023

contextflow SERACH Lung CT

912010733CFSLUNGCT4C

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: contextflow GmbH
UDI-DI code: 09120107330013
Reference / catalog number: contextflow SERACH Lung CT 1.1.0

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Manufacturer information

Organization name: contextflow GmbH
SRN: AT-MF-000001773
Manufacturer status: Active

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Critical warnings

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

CW010
- The system is not intended to be used for images of patients with life-threatening health statuses that require time-critical (immediate) medical intervention. - The system is not intended to be used for images that are subject to movement artifacts. - The system does not provide a ranking of diagnosis candidates relevant for a patient's condition. - The system does not provide comprehensive lists of diagnosis that are relevant when specific image patterns are seen. - System outputs are not intended to be used for automated and direct identification or reporting of lung anomalies.

Market distribution

Primary placement in Austria; available across 3 countries total.

Country	On market since	Until
AustriaPrimary placement		Still on market
Germany		Still on market
Netherlands		Still on market

Device identification

Trade name: contextflow SERACH Lung CT
UDI-DI code: 09120107330013
Basic UDI-DI: 912010733CFSLUNGCT4C
Reference / catalog number: contextflow SERACH Lung CT 1.1.0
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: contextflow SEARCH Lung CT is an AI-based, Content-Based Image Retrieval (CBIR) web application for 3D medical imaging data. It provides information relevant for the identification and interpretation of specific image patterns in CT (Computed Tomography) scans of the lung, such as - images with similar visual appearances from a given Knowledge Base that consists of retrospective cases - visualizations of regions with suspected pathological changes - recommendations for imaging patterns of specific regions - reference information for imaging patterns such as links to literature, articles or guidelines, tips and pitfalls, and candidates for differential diagnosis
Additional information URL: https://contextflow.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

G10 103663 0002Issued
Quality management systemNotified body: 0123Expiry: Jun 6, 2026