# K042793: Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)

- Pathway: 510(k) (Special)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Oct 29, 2004 after 22 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973598 (1997). 4 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973598: Siremobil CO2, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K040347: Siremobil Iso-C 3D, Siemens Medical Systems, Inc. (2004) Summary page 2.
- K022337: 3D Navigation Interface for Siremobile Iso-C 3D, Siemens Medical Solutions USA, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K040066: Siremobile C06, Siemens Medical Solutions USA, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K181550: Cios Spin (2018), 10 descendants of its own
- K202547: Surgivisio system (2021), 9 descendants of its own
- K203504: Cios Flow (2020), 9 descendants of its own
- K220627: SURGIVISIO Device (2022), 8 descendants of its own
- K220946: SURGIVISIO Device (2022), 7 descendants of its own

## Recalls of this device
- Dec 12, 2005 · Not classified · Z-0438-06: patient information can be stored in another patient's file.
- Aug 1, 2005 · Not classified · Z-0118-06: Screws may become loose and fall into the OR field during surgery.

## Indications for use
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.

Source page: https://510kreport.com/device/K042793
Methodology: https://510kreport.com/methodology