# K983273: XCT 2000 L PQCT Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Systems, Inc.
- Decided: Oct 29, 1998 after 42 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973104 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922286: Model XCT-900 PQCT X-Ray Bone Densitometer, Norland Corp. (1992) Summary page 1.
- K980569: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers, Norland Corp. (1998) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K983273
Methodology: https://510kreport.com/methodology