IB Lab FLAMINGO V1.0

Organization name

IB Lab GmbH

SRN

AT-MF-000006554

Manufacturer status

Active

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• CW010

  IB Lab FLAMINGO is not indicated for use on any of the following conditions: Patients age <50 years; Patients with any kind of spinal metalwork

Primary placement in Austria; available across 3 countries total.

Trade name

not provided

UDI-DI code

09120105730655

Basic UDI-DI

912010573IBLABFLAMINGOS9

Reference / catalog number

IB Lab FLAMINGO V1.0

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The IB Lab FLAMINGO is a fully-automated radiological image processing software device intended to aid users in the detection of vertebral fractures on computer tomography (CT) scans by providing: Vertebral labeling of fully visible thoracic and lumbar vertebrae; Presence/absence of vertebral fractures. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.

Additional information URL

https://www.imagebiopsy.com/

Clinical sizes

No clinical sizes registered for this device.

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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• Expiration date
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• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.