(42 days)
The XCT 2000 L performs a Quantitative Computed Tomography (QCT) scan at various user selectable skeletal sites and measures volumetric bone density (mg/cm3). It provides separate values for the inner core of the bone (trabecular region), the outer ring of the bone (cortical region), and the entire bone (Total). It also provides Axial SSI and Polar SSI values as an aid to physicians in evaluating fracture risk and bone strength. These bone density estimates can also be used as an aid to physicians in determining fracture risk.
The XCT 2000 L performs a Computed Tomography (CT) scan at various user selectable skeletal sites and measures volumetric bone density in mg/cm3. It provides separate values for the inner core of the bone (trabecular region), the outer ring of the bone (cortical region), and the entire bone (Total). It also provides Axial SSI and Polar SSI values as an aid to physicians in evaluating fracture risk and bone strength. These values are calculated from the raw data taken during the CT scan and do not require additional scan time or patient dose. The XCT 2000 L has a 140 mm measurement diameter, a selectable resolution range of 0.2 to 0.8 mm, a typical scan time of 80 seconds, and a typical dose of 40 mRems. It can do multiple scans at selectable spacing. The XCT 2000 L measures a wide variety of skeletal sites, including the Heel (os calcis), Forearm, Knee, and Tibia. The XCT 2000 L has an in vivo precision of
Here's a breakdown of the acceptance criteria and study information for the Norland XCT 2000 L pQCT Bone Densitometer, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In vivo precision (trabecular region) |
§ 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.