510(k) · Cleared
ClearedSiregraph D
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 1, 1986 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 132 later devices descend from it.
- Decided
- Apr 1, 1986
- Review
- 21 days
- Class
- Class II
- Product code
- IXR
- Recalls
- None
- Predicates
- 0
132 later devices descend from it, 1 citing it directly.
- This deviceK860913 Siregraph DSiemens Medical Solutions USA, Inc. · 1986
- Descendant · cites it directly · 131 of its ownK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- Descendant · 2 generations on · 130 of its ownK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 49 of its ownK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
Showing 5 of 132 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 132 · See all- K970734Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 1997 · cites it directly131descendants
- K992660Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · 2 generations on130descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on78descendants
- K040675Axiom Artis USiemens Medical Systems, Inc. · 2004 · 3 generations on49descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 4 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860913 | Siregraph D | Siemens Medical Solutions USA, Inc. | 1986 | — |
| +1 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +2 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| +3 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +3 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| +4 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 11 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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? (132)
See all 1321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | 1997 | 131 |
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, K970734 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 131 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/K860913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K860913: Siregraph D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860913
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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