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Cios Alpha

by Siemens Medical Solutions USA, Inc.

510(k) K210055

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK210055 Date5 Feb 2021ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0195-2024 FDA Class II initiated 12 Sep 2023

    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/repeat exposure

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OWB
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cios Alpha is an Interventional Fluoroscopic X-Ray System, a mobile C-arm machine designed to provide X-ray imaging of anatomical structures. It is used to support immediate sound decisions during interventions.

The Cios Alpha is supplied as a mobile X-Ray system and is regulated under product code OWB and regulation number 892.1650. It has been cleared by the FDA under the 510(k) clearance type, with the K number K210055. The device is intended for use in the medical specialty of Radiology.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cios Alpha used for?

    The Cios Alpha is an Interventional Fluoroscopic X-Ray System designed to provide X-ray imaging of anatomical structures. It is used to support immediate sound decisions during medical interventions in the specialty of Radiology.

  • How is the Cios Alpha supplied?

    The Cios Alpha is supplied as a mobile X-Ray system. It is regulated under product code OWB and regulation number 892.1650, and has been cleared by the FDA under the 510(k) clearance type with K number K210055.

  • What is the regulatory status of the Cios Alpha?

    The Cios Alpha has been cleared by the FDA under the 510(k) clearance type, with the K number K210055. It is intended for use in the medical specialty of Radiology and is regulated under product code OWB.

  • What are the specifications of the Cios Alpha?

    The Cios Alpha is a mobile C-arm machine designed for X-ray imaging of anatomical structures during interventions. It is classified as a Class II device and has been determined to be substantially equivalent to predicate devices.