Expert-XL Lateral Spine BMD Acquisition and Analysis Software

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

510(k) Number

K974437 ↗

FDA Product Code

KGI

Device Class

Class II

Regulation

21 CFR Part 892.1170

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Fracture Risk Assessment Option for Pixi Bone Densitometers

  Class II

  FDA 510(k) K983262 Active Cleared 18 Nov 1998

• Pixi Bone Densitometer

  Class II

  FDA 510(k) K970224 Active Cleared 16 Apr 1997

• Orca

  Class II

  FDA 510(k) K960907 Active Cleared 20 May 1996

• Prodigy Lateral View Software

  Class II

  FDA 510(k) K000826 Active Cleared 14 Apr 2000

• Pediatric Reference Data

  Class II

  FDA 510(k) K001812 Active Cleared 10 Jul 2000

• Dpx Bone Densitometer for Total Body Bone Density

  Class II

  FDA 510(k) K884625 Active Cleared 23 Jun 1989

See all devices from Lunar →

• What is the Expert-XL Lateral Spine BMD Acquisition and Analysis Software used for?

  This software is designed as an accessory for the Expert-XL bone densitometer system to acquire and analyze lateral view images of lumbar spine vertebrae. It estimates bone mineral density (BMD) in grams per square centimeter (g/cm²) and compares results against a reference population of females aged 20–49, accounting for expected BMD decline after age 50. It serves as an adjunct tool in clinical radiology settings to aid in diagnostic assessments.

• How is the Expert-XL Lateral Spine BMD Acquisition and Analysis Software supplied?

  The software is supplied as a standalone digital solution, not as a physical or sterile product. It does not require sterilization and is intended for use on compatible densitometer systems in clinical radiology environments by trained personnel. No additional hardware or consumables are included beyond the software installation.

• Is the Expert-XL Lateral Spine BMD Acquisition and Analysis Software single-use or reusable?

  The software is not a single-use product. It is designed for repeated use within a clinical setting, provided it remains installed on a properly maintained and updated system. The software’s functionality relies on the underlying hardware and system compatibility, ensuring consistent performance over time.

• What are the key specifications for acquiring BMD measurements with this software?

  The software acquires BMD measurements in a 16-second process for lateral spine images. It estimates bone mineral density in grams per square centimeter (g/cm²) and includes a reference comparison to a female population aged 20–49. The results account for expected BMD decline after age 50, providing clinically relevant insights for diagnostic purposes.

• Are there any special storage requirements for the Expert-XL Lateral Spine BMD Acquisition and Analysis Software?

  The software does not have specific storage conditions beyond standard requirements for digital systems, such as protection from physical damage, power fluctuations, and environmental factors that could compromise system performance. It should be stored on a secure, updated, and properly maintained computer system to ensure accurate and reliable operation.