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 a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2022-12-06 under approval 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. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K223409.

When was Cios Select (VA21) Image Intensifier approved by the FDA?

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

What company makes Cios Select (VA21) Image Intensifier?

Cios Select (VA21) Image Intensifier is manufactured by Siemens Medical Solutions USA, Inc..

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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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.