Devices (same UDI-DI)
1
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 09120105730655
- Basic UDI-DI Code
- 912010573IBLABFLAMINGOS9
- Reference
- IB Lab FLAMINGO V1.0
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- IB Lab GmbH
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11069092 | VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Available In Countries
🇦🇹 Austria
🇩🇪 Germany
🇳🇱 Netherlands
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