CT Eye

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 17 countries total.

Trade name

CT Eye

UDI-DI code

04779050430131

Basic UDI-DI

477905043CTEYEGQ

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

CT Eye is a software-based device capable of algorithmic interpretation of patient computed tomography (CT) images and providing the results to radiologists or other healthcare professionals. The software analyzes CT images using deep learning algorithms and generates a list of radiological findings, accompanied by heatmaps indicating their location. It supports triage by distinguishing between cases with and without pathology, produces structured reports, and highlights potential reporting discrepancies made by radiologists. CT Eye is currently validated to detect three specific radiological findings. As a software device, CT Eye is reusable with unlimited use cycles and does not require reprocessing.

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.

• Z11030592RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Certificate health across this manufacturer's portfolio.