IB Lab SQUIRREL V1.0

Organization name

IB Lab GmbH

SRN

AT-MF-000006554

Manufacturer status

Active

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• CW010

  IB Lab SQUIRREL is not indicated for use if the patient presents any of the following: Patients with the suspicion or diagnosis of: Degenerative scoliosis, Neuromuscular scoliosis, Congenital scoliosis, Juvenile Idiopathic scoliosis, Infantile Idiopathic scoliosis; Adult Idiopathic Scoliosis with secondary spinal degeneration; Patients <10 years of age; Patients with any kind of spine metalwork; Patients with spinal trauma (e.g., severely collapsed vertebra / vertebral fractures); Patients with spinal cancer or other abnormal growth

Primary placement in Austria; available across 5 countries total.

Trade name

not provided

UDI-DI code

09120105730617

Basic UDI-DI

912010573IBLABSQUIRRELDP

Reference / catalog number

IB Lab SQUIRREL 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 SQUIRREL is a fully-automated radiological image processing software device intended to aid users in the measurement of quantitative spinal alignment parameters on AP/PA full spine 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

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

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