(42 days)
No
The summary describes a standard QCT device that calculates bone density and fracture risk based on established criteria (WHO). There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The calculations appear to be based on direct measurements and predefined algorithms, not learned patterns.
No
The device measures bone density and provides aid in evaluating fracture risk and bone strength, but it does not perform any therapeutic intervention or treatment.
Yes
The device measures volumetric bone density and provides values that aid physicians in evaluating fracture risk and bone strength, which are diagnostic indicators.
No
The device description explicitly details hardware components and specifications of a Computed Tomography (CT) scanner, including measurement diameter, resolution range, scan time, and dose. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The XCT 2000 L performs a Computed Tomography (CT) scan directly on the patient's body (in vivo) to measure bone density. It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid physicians in evaluating fracture risk and bone strength by measuring bone density directly from the skeletal sites.
Therefore, the XCT 2000 L is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
90KGI
Device Description
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
§ 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.
0
OCT 79 1998
510k Summary
as required by 807.92(c) for XCT 2000 L pQCT Bone Densitometer Prepared September 1998
Submitted by: Norland Medical Systems, Inc. Contact Person: W6340 Hackbarth Road Mr. Terry Schwalenberg Fort Atkinson, WI 53538 Director Regulatory Affairs Reg. # 2124648 920-563-8456 Device Trade Name: Model XCT 2000 L pQCT Bone Densitometer Common Name: Peripheral quantitative computed tomography bone densitometer Classification: Bone densitometer, (21 CFR 892.1170), product code 90KGI: Class II Predicate Devices: Norland XCT 960 pQCT bone densitometer (K922286). Fracture Risk Assessment for Norland bone densitometers (K980569). Description of The XCT 2000 L performs a Computed Tomography (CT) scan at various Device: 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