510(k) · Cleared
ClearedXCT 2000 L PQCT Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Systems, Inc. · KGI Densitometer, Bone
Cleared on Oct 29, 1998 as substantially equivalent to K922286 (Norland Corp., 1992) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Oct 29, 1998
- Review
- 42 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973104 (1998). 3 ancestors in all, the oldest K922286 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| −1 | K980569 | Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers | Norland Corp. | 1998 | — |
| 0 (this device) | K983273 | XCT 2000 L PQCT Bone Densitometer | Medical Systems, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922286 | Model XCT-900 PQCT X-Ray Bone DensitometerSummary page 1…Peripheral quantitative computed tomography bone densitometer Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II Norland XCT 960 pQCT bone densitometer (K922286). Fracture Risk Assessment for Norland bone densitometers (K980569). The XCT 2000 L performs a Computed Tomography (CT) scan at… | 1992 |
| * | K980569 | Fracture Risk Assessment Capability for Norland X-Ray Bone DensitometersSummary page 1…densitometer, (21 CFR 892.1170), product code 90KGI; Class II Norland XCT 960 pQCT bone densitometer (K922286). Fracture Risk Assessment for Norland bone densitometers (K980569). The XCT 2000 L performs a Computed Tomography (CT) scan at various user selectable skeletal sites and measures volumetric bone… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 0 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983273: XCT 2000 L PQCT Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983273
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026