510(k) · Cleared
ClearedProdigy Lateral View 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 Apr 14, 2000 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 14, 2000
- Review
- 31 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK000826 Prodigy Lateral View SoftwareLunar Corp. · 2000
- Descendant · cites it directly · 6 of its ownK023554 Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 2002
- Descendant · 2 generations on · 2 of its ownK103475 Spineanalyer Model SapocOptasia Medical · 2011
- 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 · 2 generations on · 0 of its ownK171435 VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K023554Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 2002 · cites it directly6descendants
- K103475Spineanalyer Model SapocOptasia Medical · 2011 · 2 generations on2descendants
- 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
- K171435VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000826 | Prodigy Lateral View Software | Lunar Corp. | 2000 | — |
| +1 | K023554 | Dual-Energy Vertebral Assessment View Software | Ge Lunar Corp. | 2002 | — |
| +2 | K103475 | Spineanalyer Model Sapoc | Optasia Medical | 2011 | — |
| +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 | — |
| +2 | K171435 | VirtuOst Vertebral Fracture Assessment | O.N. Diagnostics, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 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?
- Of its descendants, K023554 (Ge Lunar Corp., 2002) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K000826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000826: Prodigy Lateral View Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000826
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026