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Organization name
UDI-DI code
Reference / catalog number

SpineQ v1.2.0 — Class IIa MDR by Bonescreen GmbH

MD Atlas
Bonescreen GmbH

EUDAMED last updated this device on Jul 6, 2025

SpineQ v1.2.0

426247034BS00001QE

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bonescreen GmbH
UDI-DI code: 04262470340024
Reference / catalog number: SpineQ v1.2.0

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Manufacturer information

Organization name: Bonescreen GmbH
SRN: DE-MF-000036576
Manufacturer status: Active

Critical warnings

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

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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262470340024
Basic UDI-DI: 426247034BS00001QE
Reference / catalog number: SpineQ v1.2.0
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

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.

EMDN nomenclature code(s)

Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

SpineQ v1.3.0426247034BS00001QEOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.