510(k) · Cleared
Recalled · Class II · 2022Axiom Sireskop SD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jul 7, 2005 as substantially equivalent to K951358 (Siemens Medical Solutions USA, Inc., 1995) and 1 other predicate after a 21-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 7, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912470 (1991). 7 ancestors in all, the oldest K860913 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 3 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 2 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 1 generation backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- This deviceK051602 Axiom Sireskop SDSiemens Medical Systems, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK111292 Luminos AgileSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK173639 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK250660 LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions · 2025 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K111292Luminos AgileSiemens Medical Solutions USA, Inc. · 2011 · cites it directly2descendants
- K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 2018 · 2 generations on1descendant
- K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −3 | 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 | — |
| −1 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| 0 (this device) | K051602 | Axiom Sireskop SD | Siemens Medical Systems, Inc. | 2005 | — |
| +1 | K111292 | Luminos Agile | Siemens Medical Solutions USA, Inc. | 2011 | 6 |
| +2 | K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | Siemens Medi Cal Solutions, Inc. | 2018 | 23 |
| +3 | K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 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? (2)
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…, the AXIOM Sireskop SD (Sireskop SX), and the AXIOM ICONOS R200 (URF Digital OT). The Sireskop SX, marketed as AXIOM Sireskop SD was described in premarket notification K951358 which received FDA Clearance on May 15, 1995. The URF Digital OT, marketed as AXIOM ICONOS R200 was described in premarket notifi… | 1995 |
| * | K992660 | Urf Digital - OTSummary page 2…in premarket notification K951358 which received FDA Clearance on May 15, 1995. The URF Digital OT, marketed as AXIOM ICONOS R200 was described in premarket notification K992660 and received FDA clearance on April 21, 1997. ' Device Description AXIOM Sireskop SD is a floor-mounted universal fluoroscopic… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111292 | Luminos Agile | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2022 | Class II | Z-1000-2023 | Process control | There is potential for the footrest to detach from the patient table during use. |
| 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 |
| Jul 13, 2010 | Not classified | Z-2222-2010 | Device Design | Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images. |
| Jan 8, 2009 | Not classified | Z-1254-2009 | Equipment maintenance | During interventional use and applications, the possibility exists for liquids to enter the systems. |
| Aug 12, 2008 | Not classified | Z-0101-2009 | Device Design | Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K111292 (Siemens Medical Solutions USA, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K951358.
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 AXIOM Sireskop SD is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
AXIOM Sireskop SD may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
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/K051602 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051602: Axiom Sireskop SD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051602
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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