Ortho Software Used W/Lunar Dpx/Dpx-L/Dps-@ Desit

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

510(k) Number

K914404 ↗

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

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• What is the Ortho Software used with Lunar DPX/DPX-L/DPS-@ Desit?

  The Ortho Software is a Class II medical device designed specifically for use with Lunar DPX/DPX-L/DPS-@ Desit bone densitometry systems. It functions as software to support bone density measurements in radiology settings.

• How is the Ortho Software supplied and what are its regulatory approvals?

  The device is supplied as software for integration with specific Lunar bone densitometry systems. It received FDA 510(k) clearance on February 27, 1992, with product code KGI and regulation number 892.1170, classified as substantially equivalent.

• What medical specialty is this software intended for?

  The Ortho Software is intended for use in radiology settings, as indicated by its review advisory committee designation as RA (Radiology). It supports bone density measurements performed by radiology professionals using compatible Lunar systems.

• What are the model compatibility requirements for this software?

  This software is specifically designed for use with Lunar DPX/DPX-L/DPS-@ Desit bone densitometry systems. It is not compatible with other manufacturer's equipment or different Lunar models outside of those specified.