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FDA 510(k)

Cios Select (VA21) Image Intensifier

K-Number: K223409 · 2022-12-06

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2022-12-06
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cios Select (VA21) Image Intensifier 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 2022-12-06 under 510(k) number K223409. 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 Select (VA21) Image Intensifier?

Cios Select (VA21) Image Intensifier is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K223409.

When did Cios Select (VA21) Image Intensifier receive FDA 510(k) clearance?

Cios Select (VA21) Image Intensifier received FDA 510(k) clearance on 2022-12-06, under 510(k) number K223409.

Who is the listed applicant for Cios Select (VA21) Image Intensifier?

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 Select (VA21) Image Intensifier?

The FDA product code for Cios Select (VA21) Image Intensifier is OWB.

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Related Devices (Code: 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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