Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 04262470340000
- Basic UDI-DI Code
- 426247034BS00001QE
- Reference
- SpineQ
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Bonescreen GmbH
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z119092 | VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
| Z11039092 | VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Available In Countries
🇩🇪 Germany
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