ChestLink

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 Lithuania; available across 18 countries total.

Trade name

ChestLink

UDI-DI code

04779050430117

Basic UDI-DI

477905043MDSCL100X8

Reference / catalog number

1

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

ChestLink automatically and autonomously (without the involvement of a radiologist) evaluates a chest X-ray study. The software is indicated to automatically detect actionable radiological findings on chest radiographs. After this analysis, one of two actions is performed: (1) If ChestLink is confident that a study has no actionable radiological findings, a report is automatically generated. The study is not reported on by a trained radiologist. (2) If ChestLink cannot confidently rule out the presence of actionable radiological findings, the study is directed to be reported on by a radiologist.

Additional information URL

No additional information URL provided by the manufacturer.

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.

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

Certificate health across this manufacturer's portfolio.