ORCA-DX BONE DENSITOMETER

• K Number: K983724
• Device Name: ORCA-DX BONE DENSITOMETER
• Manufacturer: LUNAR CORP.
• Date Cleared: 1998-12-08 ( 47 days)
• Product Code: KGI
• Regulation Number: 892.1170
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: k970224

Intended Use

The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.
The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of

Device Description

The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LUNAR ORCA-DX Bone Densitometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Safety: Total exposure dose (lower than predicate and safe)	**Radiation exposure is

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.