Eu Mdr Eu Md Class 2a On The Market 🇦🇹 Austria

IB LAB PANDA

IB Lab GmbH · 🇦🇹 Austria
Devices (same UDI-DI)
1
Certificates
0
Countries
3
Notified Bodies
0

Basic Information

Primary DI
09120105730532
Basic UDI-DI Code
912010573IBLABPANDABZ
Reference
IB LAB PANDA V1.07
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 PANDA image processing software is intended for semi-automated bone age estimation of hand radiographs. This software is intended to aid the current manual process of the Greulich & Pyle method by providing a bone age estimation for assessment through trained medical professionals. 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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