Dual-Energy Vertebral Assessment View Software

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K023554 ↗

FDA Product Code

KGI

Device Class

Class II

Regulation

21 CFR Part 892.1170

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Dual-Energy Vertebral Assessment View Software used for?

  This software is designed to process spinal scans from dual-energy X-ray absorptiometry (DXA) systems like the Prodigy or Lunar iDXA. It generates detailed images to help clinicians evaluate vertebral structure, identify deformities, and estimate vertebral heights. These assessments support fracture risk evaluation in radiology settings, but it is not intended for standalone patient diagnosis—only for use by trained operators under physician supervision.

• How is the software supplied and what hardware does it require?

  The software is supplied as a standalone application and is specifically intended for integration with compatible DXA systems, such as the Prodigy or Lunar iDXA. It does not include hardware components but relies on the densitometry system’s imaging capabilities to function. Compatibility and performance depend entirely on the integration with these approved densitometry platforms.

• Is the Dual-Energy Vertebral Assessment View Software single-use or reusable?

  The software is not classified as single-use or reusable in the traditional sense, as it is a digital application. However, its functionality depends on the underlying DXA hardware, which may have its own usage guidelines. The software itself can be reinstalled or reactivated on compatible systems, but its effectiveness relies on the integrity of the connected densitometry equipment.

• What regulatory clearance does this software hold, and how does it fit into radiology workflows?

  The software holds a 510(k) clearance (K023554) from the FDA, demonstrating substantial equivalence to existing radiology devices under the classification of a densitometer. It is categorized as Class II, indicating it is subject to general controls and special controls for radiologic devices. This clearance allows its use in clinical settings for vertebral assessment, but it must be operated by trained personnel under physician supervision to ensure accurate interpretation of results.

• Are there specific storage requirements for this software?

  The software does not have unique storage requirements beyond standard IT practices for medical imaging applications. It should be installed on a secure, compatible system with sufficient processing power to handle DXA scan data. Since it is not a physical device, environmental factors like temperature or humidity do not apply. However, the connected DXA hardware may have its own storage or maintenance specifications that should be followed to ensure optimal performance.