Fracture Risk Assessment Option for Pixi Bone Densitometers

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

510(k) Number

K983262 ↗

FDA Product Code

KGI

Device Class

Class II

Regulation

21 CFR Part 892.1170

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• 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

• Forearm Software for Lunar Dpx Series Bone Desitom

  Class II

  FDA 510(k) K915535 Active Cleared 27 Feb 1992

See all devices from Lunar →

• What clinical setting is the Fracture Risk Assessment Option designed for, and how does it integrate with existing equipment?

  The Fracture Risk Assessment Option is specifically designed for use in clinical radiology settings. It functions as a supplementary software tool that integrates directly with existing Pixi bone densitometers, enhancing their capability to evaluate fracture risk by applying WHO-defined criteria to T-score data from bone density scans.

• Is this software reusable or single-use, and what are its sterility and supply details?

  The Fracture Risk Assessment Option is a non-sterile, reusable software solution. It is supplied as part of the densitometer system, meaning no additional packaging or sterilization is required—it is already integrated and ready for use with compatible Pixi bone densitometers.

• How is the regulatory status of this device determined, and which advisory committee was involved in its clearance?

  This device holds FDA 510(k) clearance (K983262) under the Radiology Advisory Committee (RA). The clearance was granted as substantially equivalent to a predicate device, following review by the FDA’s Radiology Advisory Committee, with no third-party involvement in the process.

• What types of bone densitometers is this software compatible with, and how does it assist in clinical decision-making?

  The Fracture Risk Assessment Option is compatible with Pixi bone densitometers, as indicated by the listed registration numbers. It aids clinical decision-making by analyzing T-score values from bone density scans and applying WHO-defined criteria to assess fracture risk, helping clinicians diagnose osteoporosis and evaluate patient risk more effectively.