Veye Lung Nodules

Organization name

Aidence B.V.

SRN

NL-MF-000000534

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

Primary placement in Netherlands; available across 10 countries total.

Trade name

Veye Lung Nodules

UDI-DI code

B865VEYELUNGNOD0318X0

Basic UDI-DI

++B865VeyeLungNodules4H

Reference / catalog number

3

Issuing entity

HIBCC

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Assist physicians in their review of CT scans in the detection, classification, quantification and growth assessment of solid and sub-solid pulmonary nodules using low-dose or standard-dose and non-contrast or post-contrast scans with a maximum axial slice thickness of ≤3mm. Veye lung Nodules is intended for use as a second or concurrent reader.

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

B865VEYELUNGNOD0318X0

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

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

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE