# K973598: Siremobil CO2

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 10, 1997 after 49 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
168 later devices descend from it; 7 cite it directly.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph (2003), 88 descendants of its own
- K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf (2005), 66 descendants of its own
- K060328: Planmeca Promax 3D (2006), 61 descendants of its own
- K040675: Axiom Artis U (2004), 49 descendants of its own
- K061284: I-Cat Scanner (2006), 31 descendants of its own

## Recalls of this device
- Aug 1, 2005 · Not classified · Z-0123-06: Screws may become loose and fall into the OR field during surgery.

## Indications for use
The Siremobil C02 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 C02 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 mtra—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/K973598
Methodology: https://510kreport.com/methodology