510(k) · Cleared
Recalled · 2005Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 29, 2004 as substantially equivalent to K973598 (Siemens Medical Solutions USA, Inc., 1997) and 2 other predicates after a 22-day review. Its family tree reaches back 2 generations to 1997. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 29, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 2 generations to K973598 (1997). 4 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 1 generation backK022337 3D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc. · 2002
- This deviceK042793 Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- Descendant · cites it directly · 9 of its ownK202547 Surgivisio systemSurgivisio · 2021
- Descendant · 2 generations on · 9 of its ownK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 8 of its ownK220627 SURGIVISIO DeviceEcential Robotics · 2022
- Descendant · 2 generations on · 7 of its ownK220946 SURGIVISIO DeviceEcential Robotics · 2022
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K181550Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · cites it directly10descendants
- K202547Surgivisio systemSurgivisio · 2021 · cites it directly9descendants
- K203504Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on9descendants
- K220627SURGIVISIO DeviceEcential Robotics · 2022 · 2 generations on8descendants
- K220946SURGIVISIO DeviceEcential Robotics · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −1 | K022337 | 3D Navigation Interface for Siremobile Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K042793 | Arcadis Ordic (Available with Options 3D and 3D Navigation Interface) | Siemens Medi Cal Solutions, Inc. | 2004 | — |
| +1 | K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
| +1 | K202547 | Surgivisio system | Surgivisio | 2021 | — |
| +2 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +2 | K220627 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
| +2 | K220946 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973598 | Siremobil CO2Summary page 2…ing surgical procedures. Summary of Technological Characteristics of the Devices Compared to the Predicate: The Arcadis Orbic is a modification to the SIREMOBIL 1SO-C (K973598, cleared by CDRH as the SIREMOBIL C02 on November 10, 1997). Mechanically the changes are minor in design and style. The X-ray ge… | 1997 |
| * | K040347 | Siremobil Iso-C 3DSummary page 2…le. The X-ray generator, X-ray tube and Image Intensifier are identical with the currently cleared product. The 3D imaging option is similar to the SIREMOBIL. ISO-C 3D (K040347 cleared by CDRH on March 9, 2004). The 3D navigation interface is similar to the 3D Navigation Interface (Navilink) software for… | 2004 |
| * | K022337 | 3D Navigation Interface for Siremobile Iso-C 3DSummary page 2…ISO-C 3D (K040347 cleared by CDRH on March 9, 2004). The 3D navigation interface is similar to the 3D Navigation Interface (Navilink) software for the SIREMOBIL ISO C (K022337, cleared by CDRH on August 13, 2002). The imaging chain reflects the current standard of 10242 image processing and display with… | 2002 |
| Kept off the family tree | K040066 | FDA’s K040066 is Siremobile C06 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
What descends from it? (21)
See all 212 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 |
|---|---|---|---|---|
| Dec 12, 2005 | Not classified | Z-0438-06 | Other | patient information can be stored in another patient's file. |
| Aug 1, 2005 | Not classified | Z-0118-06 | Other | Screws may become loose and fall into the OR field during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K181550 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K973598.
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?
The Arcadis Orbic is a mobile x-ray system designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the…
Read the full statement (94 words)
The Arcadis Orbic is a mobile x-ray system designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures.
The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical 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/K042793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042793: Arcadis Ordic (Available with Options 3D and 3D Navigation Interface).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042793
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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