FDA 510(k)

Cios Alpha

K-Number: K181560 · 2018-10-24

ApplicantSiemens Medical Systems USA, Inc.

Decision Date2018-10-24

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Cios Alpha is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems USA, Inc.. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K181560. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cios Alpha?

Cios Alpha is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Siemens Medical Systems USA, Inc.. The 510(k) number is K181560.

When did Cios Alpha receive FDA 510(k) clearance?

Cios Alpha received FDA 510(k) clearance on 2018-10-24, under 510(k) number K181560.

Who is the listed applicant for Cios Alpha?

The FDA 510(k) record lists Siemens Medical Systems USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cios Alpha?

The FDA product code for Cios Alpha is OWB.

Other records listing Siemens Medical Systems USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.