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FDA 510(k)

IntraMarX 3D Radiopaque Marker

K-Number: K201106 · 2020-05-21

Decision Date2020-05-21
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IntraMarX 3D Radiopaque Marker is a medical device manufactured by Anx Robotica Corp. It received FDA 510(k) clearance on 2020-05-21 under approval number K201106. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntraMarX 3D Radiopaque Marker?

IntraMarX 3D Radiopaque Marker is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by Anx Robotica Corp. The 510(k) number is K201106.

When was IntraMarX 3D Radiopaque Marker approved by the FDA?

IntraMarX 3D Radiopaque Marker received FDA 510(k) clearance on 2020-05-21, under approval number K201106.

What company makes IntraMarX 3D Radiopaque Marker?

IntraMarX 3D Radiopaque Marker is manufactured by Anx Robotica Corp.

What is the FDA product code for IntraMarX 3D Radiopaque Marker?

The FDA product code for IntraMarX 3D Radiopaque Marker is FFX.

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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.