DPX-RX BONE DENSITOMETER

• K Number: K982267
• Device Name: DPX-RX BONE DENSITOMETER
• Manufacturer: LUNAR CORP.
• Date Cleared: 1998-08-18 ( 50 days)
• Product Code: KGI
• Regulation Number: 892.1170
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K904980 , K945526

Intended Use

The DPX-RX Bone Densitometer provides an estimate of BMD at the lumbar Spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. The use of the DPX-RX Bone Densitometer is restricted to prescription use only.

Device Description

The DPX-RX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) of the lumbar spine and the proximal femur.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Correlation with DPX-L	r > 0.98
Average BMD Values	Very similar to DPX-L in 50 subjects in vivo
Average Short-Term Precision (%CV) In Vitro

Regulation Number and Section

§ 892.1170 Bone densitometer.

(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.