# K181560: Cios Alpha

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems USA, Inc.
- Decided: Oct 24, 2018 after 132 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 68 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 79 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 4.
- K163286: ARTIS pheno, Siemens Medical Solution USA, Inc. (2017) Summary page 5.
- K051133: Arcadis Avantic, Siemens Medical Solutions USA, Inc. (2005) Summary page 5.

## Most influential descendants
- K203504: Cios Flow (2020), 9 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
- K210055: Cios Alpha (2021), 1 descendant of its own

## Recalls of this device
- Jul 30, 2020 · Class II · Z-2887-2020: Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
- 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
- Apr 20, 2020 · Class II · Z-1958-2020: Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the u
- Apr 20, 2020 · Class II · Z-1957-2020: Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the u
- Apr 17, 2020 · Class II · Z-2127-2020: The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if 
- Jun 20, 2019 · Class II · Z-1953-2019: DAP chamber may be missing an insulating foil
- Mar 22, 2019 · Class II · Z-1295-2019: Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists

## 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/K181560
Methodology: https://510kreport.com/methodology