510(k) · Cleared
ClearedArcadis Avantic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jun 1, 2005 as substantially equivalent to K040066 (Siemens Medical Solutions USA, Inc., 2004) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1991. 20 later devices descend from it.
- Decided
- Jun 1, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K912470 (1991). 16 ancestors in all, the oldest K860913 (1986). 20 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 4 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 3 generations backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- 2 generations backK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 1 generation backK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- This deviceK051133 Arcadis AvanticSiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 19 of its ownK132094 Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 15 of its ownK153244 Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- Descendant · cites it directly · 10 of its ownK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- Descendant · cites it directly · 10 of its ownK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 9 of its ownK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K132094Cios AlphaSiemens Medi Cal Solutions, Inc. · 2014 · cites it directly19descendants
- K153244Cios FusionSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on15descendants
- K181550Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · cites it directly10descendants
- K181560Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · cites it directly10descendants
- K203504Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −4 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −3 | 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 |
| −1 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| 0 (this device) | K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +1 | K132094 | Cios Alpha | Siemens Medi Cal Solutions, Inc. | 2014 | 8 |
| +2 | K153244 | Cios Fusion | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| +1 | K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
| +1 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| +2 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 OXO? 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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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 |
|---|---|---|---|
| * | K040066 | Siremobile C06Summary page 1…The ARCADIS Avantic is substantially equivalent to the following devices: Predicate Device Name 510(k) Number Clearance Date Comparable Properties Siemens Siremobil C06 K040066 02/12/2004 e Hardware Trade name: ¢ Control Software ARCADIS Varic Imaging system Siemens AXIOM Artis U K040675 06/10/2004 ¢ X-r… | 2004 |
| * | K040675 | Axiom Artis USummary page 1…earance Date Comparable Properties Siemens Siremobil C06 K040066 02/12/2004 e Hardware Trade name: ¢ Control Software ARCADIS Varic Imaging system Siemens AXIOM Artis U K040675 06/10/2004 ¢ X-ray features e [Intended use 4. Device Description: The ARCADIS Avantic is an x-ray system which consists of a mo… | 2004 |
What descends from it? (20)
See all 203 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)
No FDA recall names this device.
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 2.5 years on median.
- 12 of the 16 ancestors have a recall of any class.
- Of its descendants, K132094 (Siemens Medi Cal Solutions, Inc., 2014) has gone furthest, with 19 descendants of its own.
- 2 other devices also cite its predicate K040066.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ARCADIS Avantic is a mobile x-ray system which can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode (DCM), Subtraction, and Roadmapping, which are necessary to perform a wide variety of clinical procedures. Clinical applications may include, but are not limited to, card/vascular, gastroenterology, electrophysiology, urologic, orthopedic, neurologic, pediatrics, endoscopy, pain therapy and emergency room procedures
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/K051133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051133: Arcadis Avantic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051133
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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