510(k) · Cleared
ClearedExpert-XL Total Body Acquisition and Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar Corp. · KPS System, Tomography, Computed, Emission
Cleared on Oct 3, 1997 as substantially equivalent to K884625 (Lunar, 1989) and 1 other predicate after a 277-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 3, 1997
- Review
- 277 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884625 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK884625 DPX Bone Densitometer for Total Body Bone DensityLunar · 1989
- This deviceK965226 Expert-XL Total Body Acquisition and Analysis SoftwareLunar Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884625 | DPX Bone Densitometer for Total Body Bone Density | Lunar | 1989 | — |
| 0 (this device) | K965226 | Expert-XL Total Body Acquisition and Analysis Software | Lunar Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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 |
|---|---|---|---|
| * | K884625 | DPX Bone Densitometer for Total Body Bone DensitySummary page 1…ade Name: EXPERT-XL Total Body Acquisition and Analysis Software Common Name: Bone Densitometer Classification Name: Bone Densitometer 21CFR 892.1170 Predicate Device: K88 4625B Totai Body Software for Lunar DPX Series K93 5454 Tissue Quantitation for DPX Series 9.1 DESCRIPTION OF THE DEVICE: o The EX… | 1989 |
| * | K935454 | DPX Tissue Quantification OutputSummary page 1…sis Software Common Name: Bone Densitometer Classification Name: Bone Densitometer 21CFR 892.1170 Predicate Device: K88 4625B Totai Body Software for Lunar DPX Series K93 5454 Tissue Quantitation for DPX Series 9.1 DESCRIPTION OF THE DEVICE: o The EXPERT-XL Total Body Acquisition and Analys1s Software… | 1995 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K884625.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
EXPERT-XL® Total Body Acquisition and Analysis Software is used with the EXPERT-XL® bone densitometer system. This software acquires and estimates BMD, Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions. The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only. The operator’s manual for the EXPERT-XL system contains the following statement: “United States Federal Law restricts…
Read the full statement (123 words)
EXPERT-XL® Total Body Acquisition and Analysis Software is used with the EXPERT-XL® bone densitometer system. This software acquires and estimates BMD, Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions.
The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only. The operator’s manual for the EXPERT-XL system 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.”
The EXPERT-XL Total Body Acquisition and Analysis software requires a 3 minute exposure, with an exposure dose of 3 mrem. This software option is substantially equivalent to the DPX Total Body software and poses no new safety or efficacy concerns.
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/K965226 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965226: Expert-XL Total Body Acquisition and Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965226
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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