Fracture Risk Assessment Capability for Norland X-ray Bone Densitometers

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

510(k) Number

K980569 ↗

FDA Product Code

KGI

Device Class

Class II

Regulation

21 CFR Part 892.1170

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Model Xct-900 Pqct X-Ray Bone Densitometer

  Class II

  FDA 510(k) K922286 Active Cleared 27 Nov 1992

• Norland Model Xr-26 X-Ray Bone Densitometer

  Class II

  FDA 510(k) K881865 Active Cleared 14 Mar 1989

• Lateral Spine Opt. Xr-Series X-Ray Bone Densitomet

  Class II

  FDA 510(k) K913078 Active Cleared 24 Sep 1991

• Bone Densitometer

  Class II

  FDA 510(k) K841463 Active Cleared 17 Jul 1984

• Fracture Risk Assessment for the Norland Sxa 3000 Bone Densitometer

  Class II

  FDA 510(k) K980289 Active Cleared 12 Jun 1998

• Norland XR26 Whole Body Option

  Class II

  FDA 510(k) K901804 Active Cleared 29 Apr 1991

See all devices from Norland Corp. →

• What is the Fracture Risk Assessment Capability for Norland X-ray Bone Densitometers?

  The Fracture Risk Assessment Capability is a feature for Norland X-ray Bone Densitometers that provides bone density estimates to aid physicians in determining a patient's risk of fracture. It is designed to work specifically with Norland X-ray Bone Densitometers.

• How is the Fracture Risk Assessment Capability supplied?

  The device is manufactured by Norland Corp. and is classified as a Densitometer, Bone (product code KGI) under Class II with Special Controls. It is not described as single-use or reusable in the provided information.

• What is the regulatory status of the Fracture Risk Assessment Capability?

  The Fracture Risk Assessment Capability received FDA 510(k) clearance with number K980569 on June 12, 1998. It is intended for use in radiology settings and is classified under Class II with Special Controls.

• What are the specifications of the Fracture Risk Assessment Capability?

  The device is a feature for Norland X-ray Bone Densitometers that provides bone density estimates. It is classified as a Densitometer, Bone (product code KGI) under Class II with Special Controls. No specific measurements or technical specifications are provided in the data.