510(k) · Cleared
ClearedKXO-80G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · IZO Generator, High-Voltage, X-Ray, Diagnostic
Cleared on Dec 27, 1994 after a 40-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
- Dec 27, 1994
- Review
- 40 days
- Class
- Class I
- Product code
- IZO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK945668 KXO-80GToshiba America Medical Systems, In.C · 1994
- Descendant · cites it directly · 6 of its ownK060111 Iva (Mxa II Software Option)Hologic, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK130277 Single Energy (SE) Femur ExamsHologic, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
- Descendant · 4 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · 5 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K060111Iva (Mxa II Software Option)Hologic, Inc. · 2006 · cites it directly6descendants
- K130277Single Energy (SE) Femur ExamsHologic, Inc. · 2013 · 2 generations on5descendants
- K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · 3 generations on4descendants
- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 4 generations on2descendants
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945668 | KXO-80G | Toshiba America Medical Systems, In.C | 1994 | — |
| +1 | K060111 | Iva (Mxa II Software Option) | Hologic, Inc. | 2006 | — |
| +2 | K130277 | Single Energy (SE) Femur Exams | Hologic, Inc. | 2013 | — |
| +3 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 1 |
| +4 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +5 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 IZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060111 | Iva (Mxa II Software Option) | 2006 | 6 |
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, K060111 (Hologic, Inc., 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All IZO devicesIZO Generator, High-Voltage, X-Ray, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZO
FDA has decided no IZO device since 2007.
Median 510(k) review, days · IZO
Too few IZO 510(k)s in any year since 2007 to give a median.
Recalls per year · IZO
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZO
3in 2023
MAUDE reports naming product code IZO, 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 | 0 | — | 1 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 1 | 15 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K945668 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945668: KXO-80G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945668
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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