V1.0

Organization name

IB Lab GmbH

SRN

AT-MF-000006554

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  All outputs reported by IB Lab FROG Software have to be checked for errors by the healthcare professional trained in radiology.

Primary placement in Austria; available across 5 countries total.

Trade name

not provided

UDI-DI code

09120105730716

Basic UDI-DI

912010573IBLABFROGRB

Reference / catalog number

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

IB Lab FROG is a fully-automated radiological image processing software device intended to aid medical professionals in the measurement of anatomical parameters relevant for foot geometry assessment on plain foot 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.