1

Organization name

Oxipit, UAB

SRN

LT-MF-000022304

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Hungary; available across 7 countries total.

Trade name

not provided

UDI-DI code

D-LT-MF-000022304EQ

Basic UDI-DI

B-LT-MF-000022304EQ

Reference / catalog number

1

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The 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.

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

D-LT-MF-000022304EQ

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Certificate health across this manufacturer's portfolio.