510(k) · Cleared
ClearedDXL Calscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Demetech AB · KGI Densitometer, Bone
Cleared on May 5, 2004 as substantially equivalent to K970224 (Lunar Corp., 1997) and 2 other predicates after a 175-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- May 5, 2004
- Review
- 175 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K891582 (1989). 4 ancestors in all. 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 | K891582 | Modified Osteoanalyzer (# SPSHA110/220) | Osteon, Inc. | 1989 | — |
| −1 | K970224 | Pixi Bone Densitometer | Lunar Corp. | 1997 | — |
| 0 (this device) | K033550 | DXL Calscan | Demetech AB | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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? (3)
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 |
|---|---|---|---|
| * | K970224 | Pixi Bone DensitometerSummary page 2…~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~' '- 'demetech 807.92(a)(3) Legally marketed device (predicate device) * PIXI Bone Densitometer, GE Lunar, 510(k) K970224 & K983262 * DTX-200 Bone Densitometer, Osteometer Meditech, 510(k) K964562 807.92(a)(4) Description of the device that is… | 1997 |
| * | K983262 | Fracture Risk Assessment Option for Pixi Bone DensitometersSummary page 2…~~~~~~~~~~~~~~~~~~~~' '- 'demetech 807.92(a)(3) Legally marketed device (predicate device) * PIXI Bone Densitometer, GE Lunar, 510(k) K970224 & K983262 * DTX-200 Bone Densitometer, Osteometer Meditech, 510(k) K964562 807.92(a)(4) Description of the device that is subject o… | 1998 |
| * | K964562 | DTX-200 Bone DensitometerSummary page 2…ly marketed device (predicate device) * PIXI Bone Densitometer, GE Lunar, 510(k) K970224 & K983262 * DTX-200 Bone Densitometer, Osteometer Meditech, 510(k) K964562 807.92(a)(4) Description of the device that is subject of this premarket notification The DXL Calscan TmBone Densitometer estim… | 1997 |
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 15 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K970224.
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 DXL CalscanTM Bone Densitometer estimated bone mineral density (BMD) (g/cm 2) for the region of the heel (os calcis). By comparing estimated BMD to a young Caucasian female database, a T-score is calculated so that the physician, at his or her discretion, may assess fracture risk. One patient scan with DXL Calscan takes 55 seconds to perform. The effective patient dose is 0.02 mrem. This performance is substantially equivalent to PIXI performance and…
Read the full statement (124 words)
The DXL CalscanTM Bone Densitometer estimated bone mineral density (BMD) (g/cm 2) for the region of the heel (os calcis). By comparing estimated BMD to a young Caucasian female database, a T-score is calculated so that the physician, at his or her discretion, may assess fracture risk.
One patient scan with DXL Calscan takes 55 seconds to perform. The effective patient dose is 0.02 mrem. This performance is substantially equivalent to PIXI performance and poses no new safety or efficacy concerns.
Use of the DXL Calscan is restricted to prescription use only. The Operator's Manual for the DXL Calscan contains the following statement:
"United States Federal Law restricts this device to the sale, distribution and use by or on the order of a physician."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033550: DXL Calscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033550
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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