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FDA 510(k)

Sirius MRI Marker NS

K-Number: K171487 · 2017-08-25

ApplicantC4 Imaging, LLC
Decision Date2017-08-25
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sirius MRI Marker NS is the device name listed in this FDA 510(k) record. The listed applicant is C4 Imaging, LLC. It received FDA 510(k) clearance on 2017-08-25 under 510(k) 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. The listed applicant is C4 Imaging, LLC. The 510(k) number is K171487.

When did Sirius MRI Marker NS receive FDA 510(k) clearance?

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

Who is the listed applicant for Sirius MRI Marker NS?

The FDA 510(k) record lists C4 Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing C4 Imaging, LLC 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.

K192771C4 Fiducial MarkerK180069HDR MRI Lumen Marker

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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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