Expert-XL Total Body Acquisition and Analysis Software

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

510(k) Number

K965226 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K960907 Active Cleared 20 May 1996

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• What clinical measurements does the Expert-XL Total Body Acquisition and Analysis Software provide?

  The software processes scan data from computed tomography emission (CTE) systems to deliver objective measurements of bone mineral density (BMD), lean tissue mass, and fat tissue mass. These metrics are segmented for total body assessment as well as sub-regions, aiding clinical evaluation of body composition and metabolic health.

• How is the Expert-XL Total Body Acquisition and Analysis Software supplied, and what system does it require?

  This software is supplied as a digital product exclusively for use with the Expert-XL bone densitometer system. It is not a standalone device but an accessory that processes scan data generated by the densitometer, requiring integration with its hardware for operation.

• Is the Expert-XL Total Body Acquisition and Analysis Software single-use or reusable, and does it require sterilization?

  The software is a digital product with no physical components that require sterilization or single-use disposal. It is designed for repeated use within compatible Expert-XL systems, provided the underlying hardware adheres to manufacturer guidelines for maintenance and calibration.

• What is the scan time required for the Expert-XL Total Body Acquisition and Analysis Software to process measurements?

  The software processes data acquired during a 3-minute scan performed by the linked Expert-XL bone densitometer system. The scan duration is determined by the densitometer’s hardware, while the software analyzes the resulting data to generate quantitative metrics for clinical assessment.

• Can the Expert-XL Total Body Acquisition and Analysis Software be used in MRI environments?

  No, the software is not intended for use in MRI environments. It is specifically designed for computed tomography emission (CTE) applications and must be operated within systems compatible with its intended imaging modality, excluding MRI compatibility.