FDA 510(k)

Cios Spin

K-Number: K210054 · 2021-02-05

ApplicantSiemens Medical Systems USA, Inc.

Decision Date2021-02-05

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Cios Spin 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 2021-02-05 under 510(k) number K210054. 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 Spin?

Cios Spin is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Siemens Medical Systems USA, Inc.. The 510(k) number is K210054.

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

Cios Spin received FDA 510(k) clearance on 2021-02-05, under 510(k) number K210054.

Who is the listed applicant for Cios Spin?

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 Spin?

The FDA product code for Cios Spin 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.

K181560Cios Alpha

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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.