Fracture Risk Assessment Option for DPX Series Bone Densitometers

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

510(k) Number

K983271 ↗

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 fracture risk assessment option for DPX series bone densitometers used for?

  This device is a fracture risk assessment option designed to be used with DPX series bone densitometers to evaluate fracture risk in radiology settings, as indicated by its FDA classification under regulation 892.1170 and product code KGI for bone densitometry devices.

• How was the fracture risk assessment option for DPX series bone densitometers authorized for market release?

  The device received traditional 510(k) clearance (K983271) from the FDA on November 18, 1998, demonstrating substantial equivalence to a predicate device, which is the regulatory pathway used for its authorization.

• Who manufactures the fracture risk assessment option for DPX series bone densitometers and where is it produced?

  The device is manufactured by Lunar Corp. in Madison, Wisconsin, as specified in the manufacturer and address details provided in the device data.