510(k) · Cleared
Recalled · 2011Axiom Artis U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 10, 2004 as substantially equivalent to K992660 (Siemens Medical Solutions USA, Inc., 1999) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1991. 49 later devices descend from it. It has been recalled once.
- Decided
- Jun 10, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K912470 (1991). 9 ancestors in all, the oldest K860913 (1986). 49 later devices descend from it, 4 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 deviceK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004
- Descendant · cites it directly · 20 of its ownK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 2 generations on · 19 of its ownK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- Descendant · cites it directly · 16 of its ownK100371 Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011
- Descendant · 3 generations on · 15 of its ownK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 14 of its ownK182907 SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K051133Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005 · cites it directly20descendants
- K132094Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · 2 generations on19descendants
- K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011 · cites it directly16descendants
- K153244Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on15descendants
- K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019 · 2 generations on14descendants
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) | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | — |
| +1 | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +2 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| +1 | K100371 | Spy Intra-Operative Imaging System | Novadaq Technologies, Inc. | 2011 | — |
| +3 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| +2 | K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K992660 | Urf Digital - OTSummary page 1…m, the AXIOM ICONOS R200 (URF Digital OT), the Powermobil and the AXIOM Attis FC. The URF Digital OT, market as AXIOM ICONOS R200 was described in premarket notification K992660 and received FDA clearance on April 21, 1997. The Siremobil C02, market as Powermobil was described in_premarket notification K97… | 1999 |
| * | K973598 | Siremobil CO2Summary page 1…described in premarket notification K992660 and received FDA clearance on April 21, 1997. The Siremobil C02, market as Powermobil was described in_premarket notification K973598 which received FDA Clearance on November 10, 1997. The AXIOM Artis FC was described in premarket notification K010721 which recei… | 1997 |
| * | K010721 | Axiom Artis Modular Angiography SystemSummary page 1…Powermobil was described in_premarket notification K973598 which received FDA Clearance on November 10, 1997. The AXIOM Artis FC was described in premarket notification K010721 which received FDA Clearance on March 30, 2001. information that substantiates this claim of equivalence is provided throughout… | 2001 |
What descends from it? (49)
See all 494 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 |
|---|---|---|---|---|
| Jun 29, 2011 | Not classified | Z-3009-2011 | Labeling False and Misleading | When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 7 of the 9 ancestors have a recall of any class.
- Of its descendants, K051133 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K992660.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
AXIOM Artis U is an angiography system developed for diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis U include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g., Gastro-intestinal imaging, Skeletal imaging etc.
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/K040675 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040675: Axiom Artis U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040675
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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