Prodigy Lateral View Software

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

510(k) Number

K000826 ↗

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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• Pixi Bone Densitometer

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• Orca

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• Dpx Bone Densitometer for Total Body Bone Density

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• Forearm Software for Lunar Dpx Series Bone Desitom

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• What is the Prodigy Lateral View Software used for?

  The Prodigy Lateral View Software is designed specifically for analyzing lateral spinal and hip radiographs to measure bone mineral density (BMD). It provides quantitative assessments of vertebral fractures and overall bone health, aiding radiologists in diagnostic evaluations. This tool is not intended for general imaging but focuses on targeted densitometry analysis.

• How is the Prodigy Lateral View Software supplied and does it require integration?

  The software is supplied as a digital application and is not a physical device. It requires integration with compatible densitometry systems to function, as it operates as a standalone analytical tool for processing radiographic images. This means it cannot be used independently of imaging hardware.

• Is the Prodigy Lateral View Software single-use or reusable?

  The Prodigy Lateral View Software is neither single-use nor reusable in the traditional sense, as it is a digital application. It is intended for repeated use across compatible systems, provided the software remains updated and the underlying hardware meets operational requirements. There are no explicit sterility requirements for this software.

• What regulatory classification does the Prodigy Lateral View Software hold?

  The Prodigy Lateral View Software is classified under FDA Class II regulatory classification, specifically under product code KGI (Densitometer, Bone). It holds a Traditional 510(k) clearance (K000826) for radiology applications, indicating it has been deemed substantially equivalent to a predicate device. This classification reflects its role in diagnostic imaging and bone health assessments.

• Does the Prodigy Lateral View Software have any safety considerations for MRI environments?

  The provided documentation does not explicitly state any MRI safety requirements or considerations for the Prodigy Lateral View Software. Since it is a software application designed for radiology diagnostics, its use is limited to environments where compatible densitometry systems are operational. Users should confirm compatibility with their specific imaging hardware and follow manufacturer guidelines for safe operation.