V2.0

Organization name

IB Lab GmbH

SRN

AT-MF-000006554

Manufacturer status

Active

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• CW010

  All findings reported by the Software have to be checked for errors by a medical professional trained in radiology.

Primary placement in Austria; available across 5 countries total.

Trade name

not provided

UDI-DI code

09120105730747

Basic UDI-DI

912010573IBLABLAMAPE

Reference / catalog number

V2.0

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

IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the estimation of leg length discrepancy and quantitative lower limb alignment parameters on uni- and bilateral AP full leg radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.