510(k) · Cleared
ClearedPolydoros SX 65 and 80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IZO Generator, High-Voltage, X-Ray, Diagnostic
Cleared on Apr 3, 1995 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Apr 3, 1995
- Review
- 34 days
- Class
- Class I
- Product code
- IZO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK950883 Polydoros SX 65 and 80Siemens Medical Solutions USA, Inc. · 1995
- Descendant · cites it directly · 8 of its ownK013999 Lodox, Model BaselineLodox Systems (Pty), Ltd. · 2002
- Descendant · 2 generations on · 7 of its ownK071546 EOSBiospace Med · 2007 · Recalled
- Descendant · 3 generations on · 6 of its ownK120721 EOSEos Imaging · 2012
- Descendant · 3 generations on · 5 of its ownK123740 EOSEos Imaging · 2013 · Recalled
- Descendant · 4 generations on · 4 of its ownK142773 EOS SystemEos Imaging · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K013999Lodox, Model BaselineLodox Systems (Pty), Ltd. · 2002 · cites it directly8descendants
- K071546EOSBiospace Med · 2007 · 2 generations on7descendants
- K120721EOSEos Imaging · 2012 · 3 generations on6descendants
- K123740EOSEos Imaging · 2013 · 3 generations on5descendants
- K142773EOS SystemEos Imaging · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950883 | Polydoros SX 65 and 80 | Siemens Medical Solutions USA, Inc. | 1995 | — |
| +1 | K013999 | Lodox, Model Baseline | Lodox Systems (Pty), Ltd. | 2002 | — |
| +2 | K071546 | EOS | Biospace Med | 2007 | 1 |
| +3 | K120721 | EOS | Eos Imaging | 2012 | — |
| +3 | K123740 | EOS | Eos Imaging | 2013 | 1 |
| +4 | K142773 | EOS System | Eos Imaging | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013999 | Lodox, Model Baseline | 2002 | 8 |
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, K013999 (Lodox Systems (Pty), Ltd., 2002) has gone furthest, with 8 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/K950883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950883: Polydoros SX 65 and 80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950883
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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