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FDA 510(k)

Cios Fusion

K-Number: K153244 · 2016-03-07

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-03-07
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cios Fusion is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-03-07 under 510(k) number K153244. 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 Fusion?

Cios Fusion is a medical device that received FDA 510(k) clearance on 2016-03-07. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K153244.

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

Cios Fusion received FDA 510(k) clearance on 2016-03-07, under 510(k) number K153244.

Who is the listed applicant for Cios Fusion?

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

What is the FDA product code for Cios Fusion?

The FDA product code for Cios Fusion is OWB.

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Official Source

View on FDA Database →

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

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