510(k) · Cleared
ClearedProdigy Total Body Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar Corp. · KGI Densitometer, Bone
Cleared on Dec 8, 1998 as substantially equivalent to K884625 (Lunar, 1989) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Dec 8, 1998
- Review
- 56 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884625 (1989). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884625 DPX Bone Densitometer for Total Body Bone DensityLunar · 1989
- This deviceK983564 Prodigy Total Body SoftwareLunar Corp. · 1998
- Descendant · cites it directly · 1 of its ownK052581 Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · cites it directly · 0 of its ownK072439 GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007
Most influential descendants
Showing 3 of 3 · See all- K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · cites it directly1descendant
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 2 generations on0descendants
- K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007 · cites it directly0descendants
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) | K983564 | Prodigy Total Body Software | Lunar Corp. | 1998 | — |
| +1 | K052581 | Lunar Idxa | Ge Medical Systems Ultrasound and Primary Care Dia | 2005 | 1 |
| +2 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +1 | K072439 | GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit | Ge Medical Systems Ultrasound and Primary Care Dia | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K884625 | DPX Bone Densitometer for Total Body Bone DensitySummary page 1…713 (608) 288-6460 (608) 274-0853 October 9, 1998 Prodigy Total Body Software Bone Densitometer Bone Densitometer 21CFR 892.1170 LUNAR DPX Total Body Software 510(k) K884625/B LUNAR DPX Total Body Tissue Quantitation Software 510(k) K935454 10.1 DESCRIPTION OF THE DEVICE: The Total Body Software for… | 1989 |
| * | K935454 | DPX Tissue Quantification OutputSummary page 1…dy Software Bone Densitometer Bone Densitometer 21CFR 892.1170 LUNAR DPX Total Body Software 510(k) K884625/B LUNAR DPX Total Body Tissue Quantitation Software 510(k) K935454 10.1 DESCRIPTION OF THE DEVICE: The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Minera… | 1995 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician. The Total Body Software requires a 5-minute exposure, with a total effective dose of 0.13 mrem. This software is substantially equivalent to the DPX Total Body software and poses no new safety or efficacy…
Read the full statement (122 words)
The Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician.
The Total Body Software requires a 5-minute exposure, with a total effective dose of 0.13 mrem. This software is substantially equivalent to the DPX Total Body software and poses no new safety or efficacy concerns.
The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator’s manual for the Prodigy 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.”
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/K983564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983564: Prodigy Total Body Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983564
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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