510(k) · Cleared
Recalled · 2009Siregraph CF
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 Mar 11, 1996 as substantially equivalent to K951358 (Siemens Medical Solutions USA, Inc., 1995) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1991. 132 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 11, 1996
- Review
- 53 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 1 generation to K912470 (1991). 3 ancestors in all. 132 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- This deviceK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996
- 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 |
|---|---|---|---|---|---|
| −1 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| 0 (this device) | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
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), the FDA summary (predicates and indications), 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951358 | Sireskop SXSummary page 2…is substantially equivalent to the following medical devices currently in commercial distribution. Model Company FDA K-Number Sireskop SX Siemens Medical Systems, Inc. K951358 Prestilix 1600X GE Medical Systems K924310 Diagnost 96 Philip Medical Systems K912470 (/16 Z 76 Kathleen Rutherford Date / Manag… | 1995 |
| * | K924310 | Prestilix 1694 D Image Intensified FluorosccopicSummary page 2…g medical devices currently in commercial distribution. Model Company FDA K-Number Sireskop SX Siemens Medical Systems, Inc. K951358 Prestilix 1600X GE Medical Systems K924310 Diagnost 96 Philip Medical Systems K912470 (/16 Z 76 Kathleen Rutherford Date / Manager, Regulatory Submissions | 1993 |
| * | K912470 | Philips Diagnost 96Summary page 2…istribution. Model Company FDA K-Number Sireskop SX Siemens Medical Systems, Inc. K951358 Prestilix 1600X GE Medical Systems K924310 Diagnost 96 Philip Medical Systems K912470 (/16 Z 76 Kathleen Rutherford Date / Manager, Regulatory Submissions | 1991 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2009 | Not classified | Z-0189-2010 | Device Design | possible injury to hand/fingers |
| Jun 7, 2004 | Not classified | Z-1475-04 | Other | X-ray tube movement when table is tilted more than 90 degrees |
| Jun 7, 2004 | Not classified | Z-1476-04 | Other | X-ray tube movement when table is tilted more than 90 degrees |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The Siemens Siregraph CF is a remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation in the hospital and clinical environment. The Siregraph CF, remote X-ray system, has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoraic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960266: Siregraph CF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960266
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026