LUNAR EXPERT

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

510(k) Number

K945526 ↗

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 LUNAR EXPERT device used for?

  The LUNAR EXPERT is a bone densitometer device designed for analyzing bone mineral content and bone morphometry. It is intended for use in radiology settings to help assess and manage conditions related to bone density.

• How is the LUNAR EXPERT device supplied?

  The LUNAR EXPERT is manufactured by Lunar Corp. and is supplied in various models as indicated by the multiple registration numbers. The device is not specified as single-use or reusable in the provided data.

• What is the regulatory status of the LUNAR EXPERT?

  The LUNAR EXPERT received FDA 510(k) clearance on April 25, 1995, with K number K945526. It is classified as a Class II medical device under product code KGI for radiology applications.

• What are the specifications of the LUNAR EXPERT bone densitometer?

  The LUNAR EXPERT is a bone densitometer device with specifications including device class II, product code KGI, and multiple registration numbers. It is designed for radiology applications and received a decision code of SESE (Substantially Equivalent).