# K210055: Cios Alpha

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 5, 2021 after 28 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: 12 generations back to K801623 (1980). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181560: Cios Alpha, Siemens Medical Systems USA, Inc. (2018) Summary page 4.
- K203504: Cios Flow, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Most influential descendants
- K251520: Cios Alpha; Cios Flow (2025), 0 descendants of its own

## Recalls of this device
- Sep 12, 2023 · Class II · Z-0195-2024: Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repea

## 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, 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/K210055
Methodology: https://510kreport.com/methodology