# K132094: Cios Alpha

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Mar 11, 2014 after 246 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K912470 (1991). 17 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051133: Arcadis Avantic, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K203504: Cios Flow (2020), 9 descendants of its own
- K181767: Cios Select (2018), 5 descendants of its own

## Recalls of this device
- Jul 14, 2020 · Class II · Z-2848-2020: Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause perma
- Nov 25, 2019 · Class II · Z-0782-2020: During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformat
- Jun 20, 2019 · Class II · Z-1953-2019: DAP chamber may be missing an insulating foil
- Mar 18, 2019 · Class II · Z-1298-2019: Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes
- Feb 19, 2016 · Class II · Z-1278-2016: Software issues on Cios Alpha mobile C-Arm system
- Feb 16, 2016 · Class II · Z-1281-2016: Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an 
- Aug 17, 2015 · Class II · Z-0118-2016: patient procedure interruption due to a potential system failure
- May 5, 2015 · Class II · Z-1958-2015: under certain circumstances the Cios Alpha system may freeze during a procedure.

## Indications for use
The Cios Alpha 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, gastro-intestinal, 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/K132094
Methodology: https://510kreport.com/methodology