# K153147: Cios Connect

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 12, 2016 after 74 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K912470 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040066: Siremobile C06, Siemens Medical Solutions USA, Inc. (2004) Summary page 5.
- K132094: Cios Alpha, Siemens Medi Cal Solutions, Inc. (2014) Summary page 5.

## Indications for use
The Cios Connect 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 Cios Connect 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/K153147
Methodology: https://510kreport.com/methodology