ChestEye

Organization name

Oxipit, UAB

SRN

LT-MF-000022304

Manufacturer status

Active

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• CW010

  Always read the instructions for use before using the device.

Primary placement in Austria; available across 18 countries total.

Trade name

ChestEye

UDI-DI code

04779050430100

Basic UDI-DI

477905043MDSCE220W2

Reference / catalog number

2

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Oxipit ChestEye software is intended to support trained radiologists when reporting on chest X-ray images. The final report must be approved by a trained radiologist. The software is a fully automatic computer assisted diagnosis solution. Based on collected data (deep neural network) the software analyses a given chest X-ray image. By function, ChestEye consists of four parts: ChestEye CAD, ChestEye Queue, ChestEye Search and ChestEye Quality. Depending on the configuration, the result of the analysis is: – A preliminary text report with detected pathologies optionally with heat maps representing location of each finding (ChestEye CAD) and a reporting priority/urgency level (ChestEye Queue); – List of retrospective cases with similar radiological findings (ChestEye Search); – Identification of potential reporting errors made by the reporting radiologists (ChestEye Quality).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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• Software identification

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

• Z129082VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES

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