FDA 510(k)

Sirius MRI Marker NS

K-Number: K171487 · 2017-08-25

Decision Date2017-08-25

Product CodeKXK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Sirius MRI Marker NS is a medical device manufactured by C4 Imaging, LLC. It received FDA 510(k) clearance on 2017-08-25 under approval number K171487. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sirius MRI Marker NS?

Sirius MRI Marker NS is a medical device that received FDA 510(k) clearance on 2017-08-25. It is manufactured by C4 Imaging, LLC. The 510(k) number is K171487.

When was Sirius MRI Marker NS approved by the FDA?

Sirius MRI Marker NS received FDA 510(k) clearance on 2017-08-25, under approval number K171487.

What company makes Sirius MRI Marker NS?

Sirius MRI Marker NS is manufactured by C4 Imaging, LLC.

What is the FDA product code for Sirius MRI Marker NS?

The FDA product code for Sirius MRI Marker NS is KXK.

Other Devices by C4 Imaging, LLC

K180069HDR MRI Lumen Marker K192771C4 Fiducial Marker

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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.