FDA 510(k)

HDR MRI Lumen Marker

K-Number: K180069 · 2018-04-27

Decision Date2018-04-27

Product CodeJAQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HDR MRI Lumen Marker is a medical device manufactured by C4 Imaging, LLC. It received FDA 510(k) clearance on 2018-04-27 under approval number K180069. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDR MRI Lumen Marker?

HDR MRI Lumen Marker is a medical device that received FDA 510(k) clearance on 2018-04-27. It is manufactured by C4 Imaging, LLC. The 510(k) number is K180069.

When was HDR MRI Lumen Marker approved by the FDA?

HDR MRI Lumen Marker received FDA 510(k) clearance on 2018-04-27, under approval number K180069.

What company makes HDR MRI Lumen Marker?

HDR MRI Lumen Marker is manufactured by C4 Imaging, LLC.

What is the FDA product code for HDR MRI Lumen Marker?

The FDA product code for HDR MRI Lumen Marker is JAQ.

Other Devices by C4 Imaging, LLC

K171487Sirius MRI Marker NS 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.