# K040066: Siremobile C06

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 12, 2004 after 30 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- 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 K910115 (1991). 6 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963093: Siremobil Compact, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.
- K973598: Siremobil CO2, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K051133: Arcadis Avantic (2005), 20 descendants of its own
- K132094: Cios Alpha (2014), 19 descendants of its own
- K153244: Cios Fusion (2016), 15 descendants of its own
- K181550: Cios Spin (2018), 10 descendants of its own
- K181560: Cios Alpha (2018), 10 descendants of its own

## Recalls of this device
- Dec 12, 2005 · Not classified · Z-0439-06: patient information can be stored in another patient's file.
- Aug 1, 2005 · Not classified · Z-0119-06: Screws may become loose and fall into the OR field during surgery.

## Indications for use
The Siremobil C06 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil C06 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Source page: https://510kreport.com/device/K040066
Methodology: https://510kreport.com/methodology