# K153244: Cios Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 7, 2016 after 119 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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
Longest line of descent: 7 generations back to K912470 (1991). 18 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K203504: Cios Flow (2020), 9 descendants of its own
- K181767: Cios Select (2018), 5 descendants of its own
- K210054: Cios Spin (2021), 3 descendants of its own
- K210309: Cios Select (VA21) Flat Panel (2021), 2 descendants of its own
- K223410: Cios Select (VA21) Flat Panel (2022), 1 descendant of its own

## Recalls of this device
- Jun 20, 2019 · Class II · Z-1954-2019: DAP chamber may be missing an insulating foil

## Indications for use
The Cios Fusion is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

Source page: https://510kreport.com/device/K153244
Methodology: https://510kreport.com/methodology