Bone Densitometer

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

510(k) Number

K841463 ↗

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

• Fracture Risk Assessment for the Norland Sxa 3000 Bone Densitometer

  Class II

  FDA 510(k) K980289 Active Cleared 12 Jun 1998

• Fracture Risk Assessment Capability for Norland X-ray Bone Densitometers

  Class II

  FDA 510(k) K980569 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 clinical sites does the Bone Densitometer measure bone mineral density at, and why is this important for patient assessment?

  The Bone Densitometer is specifically designed to measure bone mineral density at standard clinical sites such as the anteroposterior (AP) spine and the proximal femur. These sites are critical for assessing skeletal health because they are common fracture-prone areas in conditions like osteoporosis. By evaluating these regions, clinicians can better predict fracture risk and tailor treatment plans to prevent bone-related complications.

• Is the Bone Densitometer intended for single-use or reusable applications, and how does this affect its maintenance and usage environment?

  The Bone Densitometer is supplied as a reusable clinical instrument, meaning it is designed for repeated use in radiology settings. This classification implies that it requires proper cleaning, calibration, and maintenance between patient uses to ensure accuracy and reliability. Its reusable nature also means it should be stored in a controlled environment, such as a dedicated radiology department, to prevent contamination and damage.

• What regulatory pathway was followed for the Bone Densitometer’s FDA clearance, and how does this classification impact its use in clinical settings?

  The Bone Densitometer received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent (SESE) under product code KGI (Densitometer, Bone) and regulated as a Class II device. This means it meets special controls and was reviewed by the Radiology (RA) advisory committee. Clinically, this classification ensures it adheres to established safety and performance standards for bone density measurement, allowing trusted use in radiology departments for fracture risk assessment and osteoporosis management.

• Does the Bone Densitometer use a specific imaging technology, and how does this differ from other bone density measurement tools?

  Yes, the Bone Densitometer employs pencil beam technology, which provides precise measurements of bone mineral density at targeted skeletal sites. Unlike broader imaging techniques (e.g., dual-energy X-ray absorptiometry or DEXA), pencil beam technology offers focused, high-resolution scans ideal for clinical sites like the spine and proximal femur. This specificity helps clinicians assess localized bone health with greater accuracy for conditions such as osteoporosis.