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The Accudxa 2 is a dual-energy x-ray (DXA) device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. Accudxa 2 BMD estimates, t-score and z-score can be used as an aid to the physician in determining fracture risk and for monitoring changes in bone mass over time.

The Accudxa 2 Model 7200 is a Dual Energy X-ray Absorptiometer (DXA) screening device. The device is intended to calculate an index of bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, vielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals, which can be used by the physician as an aid to diagnose osteoporosis or osteopenia and to estimate fracture risk. The z-score is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient, which can be used by the physician as an aid to diagnose other disorders affecting bone mass. The BMD Test interaction with the operator is through a touchscreen LCD panel and a membrane switch/indicator panel on the front of the device. BMD Test options are presented to the operator through messages on the touchscreen. The x-ray system state and x-ray controls are presented to the operator via the membrane switch/indicator panel on the front of the device. The Accudxa 2 is a Class II medical device and a Class II laser product.