510(k) · Cleared
Recalled · 2011Sireskop SX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on May 15, 1995 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 133 later devices descend from it. It has been recalled 2 times.
- Decided
- May 15, 1995
- Review
- 52 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 2
- Predicates
- 0
133 later devices descend from it, 2 citing it directly.
- This deviceK951358 Sireskop SXSiemens Medical Solutions USA, Inc. · 1995
- Descendant · cites it directly · 132 of its ownK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 131 of its ownK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- Descendant · 3 generations on · 130 of its ownK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- Descendant · 4 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 49 of its ownK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K960266Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · cites it directly132descendants
- K970734Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 1997 · 2 generations on131descendants
- K992660Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · 3 generations on130descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on78descendants
- K040675Axiom Artis USiemens Medical Systems, Inc. · 2004 · 4 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951358 | Sireskop SX | Siemens Medical Solutions USA, Inc. | 1995 | — |
| +1 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| +2 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +3 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| +4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +4 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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? (133)
See all 1332 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2011 | Not classified | Z-1421-2011 | Other | Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing |
| Jan 8, 2009 | Not classified | Z-1253-2009 | Equipment maintenance | During interventional use and applications, the possibility exists for liquids to enter the systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K960266 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 132 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K951358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951358: Sireskop SX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951358
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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