SpineQ v1.3.0

Organization name

Bonescreen GmbH

SRN

DE-MF-000036576

Manufacturer status

Active

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• CW999

  Consult instructions for use: SpineQ is not intended for use in adolescents or children, nor for neonatology. SpineQ is not intended for other imaging modalities (e.g., MRI, cone beam CT). SpineQ is not intended to replace the review of the source CT images. SpineQ is not intended to replace the final judgment by the practitioner (i.e., healthcare professional). The information provided by SpineQ is not intended to be the only source of information for taking medical decisions. SpineQ is not intended to be used to automatically deliver therapies and treatments.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04262470340031

Basic UDI-DI

426247034BS00001QE

Reference / catalog number

SpineQ v1.3.0

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

SpineQ is a stand-alone software as medical device that analyzes existing imaging data in computed tomography (CT) scans to estimate quantitative and structural parameters of bone health. SpineQ is based on a segmentation and identification of the bones of interest, calibration of the intensity values, and extraction of relevant structural and quantitative features. The retrospective analyses allow the extraction of information without exposing the patient to additional ionizing radiation. SpineQ can help a physician to identify osteoporosis or other conditions of impaired bone health.

Additional information URL

https://bonescreen.de/

Clinical sizes

No clinical sizes registered for this device.

• Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

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