510(k) · Cleared
ClearedKoordinat M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IXR Table, Radiographic, Tilting
Cleared on Apr 20, 1995 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 83 later devices descend from it.
- Decided
- Apr 20, 1995
- Review
- 36 days
- Class
- Class II
- Product code
- IXR
- Recalls
- None
- Predicates
- 0
83 later devices descend from it, 2 citing it directly.
- This deviceK951176 Koordinat MSiemens Medical Solutions USA, Inc. · 1995
- Descendant · cites it directly · 81 of its ownK013826 Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · cites it directly81descendants
- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on78descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 3 generations on43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951176 | Koordinat M | Siemens Medical Solutions USA, Inc. | 1995 | — |
| +1 | K013826 | Axiom Aristos FX (Multi Purpose Radiography System) | Siemens Medical Systems, Inc. | 2002 | 8 |
| +2 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +3 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +3 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +4 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 IXR? 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? (83)
See all 832 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, K013826 (Siemens Medical Systems, Inc., 2002) has gone furthest, with 81 descendants of its own.
How does its category compare?
All IXR devicesIXR Table, Radiographic, Tilting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXR
FDA has decided no IXR device since 2007.
Median 510(k) review, days · IXR
Too few IXR 510(k)s in any year since 2007 to give a median.
Recalls per year · IXR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXR
1in 2024
MAUDE reports naming product code IXR, 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 | 4 |
| 2008 | 0 | — | 4 | 8 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 5 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 164 |
| 2013 | 0 | — | 0 | 196 |
| 2014 | 0 | — | 0 | 120 |
| 2015 | 0 | — | 0 | 82 |
| 2016 | 0 | — | 1 | 58 |
| 2017 | 0 | — | 1 | 25 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K951176 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951176: Koordinat M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951176
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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